v>EPA Unrt»d StatW Environmental Protection Office of Pwticidw ind Toxic Subm Wuhington OC 20460 September 1985 Guidance for the Reregistration of Pesticide Products Containing Bentazon as the Active Ingredient ------- GUIDANCE FOR THE REREGISTRATION OF PESTICIDE PRODUCTS CONTAINING BENTAZON AS THE ACTIVE INGREDIENT EPA CASE NUMBER: 182 ENVIRONMENTAL PROTECTION AGENCY OFFICE OF PESTICIDE PROGRAMS WASHINGTON, D.C. 20460 SEPTEMBER 1985 ------- TABLE OF CONTENTS Page Introduction 1 I. Regulatory Assessment 4 II. Requirement for Submission of Generic Data 29 III. Requirement for Submission of Product-Specific Data 59 IV. Submission of Revised Labeling 63 A. Label Contents 63 B. Collateral Information 69 V. Instructions for Submission 69 ------- APPENDICES Page II-l Guide to Bibliography 73 II-2 Bibliography 75 II-3 FIPRA §3(c)(2)(B) Summary Sheet - EPA Form 8580-1 . . 95 II-4 Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data EPA Form 8580-2 97 III-l Product Specific Data Report (End-Use Products) . . 98 IV-1 40 CFR 162.10 Labeling Requirements 99 IV-2 Table of Labeling Requirements Ill IV-3 Physical/Chemical Hazards Labeling Statement. . . . 114 IV-4 Pesticide Storage Instructions 115 IV-5 Pesticide Disposal Instructions 115 IV-6 Container Disposal Instructions 12i ii ------- INTRODUCTION The Federal Insecticide, Fungicide, and Rodenticlde Act (FIFRA sec. 3(g)) directs EPA to reregister all pesticides as expeditiously as possible. To carry out this task, EPA has established the Regis- tration Standards program, which will review all pesticide products containing active Ingredients first registered before January 1, 1977. Pesticides will be reviewed in use clusters which have been ranked to give earliest review to pesticides used on food and feed crops. The Registration Standards program Involves a thorough review of the scientific data base underlying pesticide registrations and an identification of essential but missing studies which may not have been required when the product was initially registered or studies that are now considered insufficient. EPA's reassessment results in the development of a regulatory position, contained in a Registration Standard, on each pesticide and its uses. The Agency may require the registrant to modify product labels to provide additional precautionary statements, restrict the use of the pesticide to certified applicators, provide reentry intervals, modify uses or formulation types, specify certain packaging limitations, or other requirements to assure that proper use of the pesticide will not result in adverse effects on the environment. The scientific review, which is not contained in this Guidance Package but is available from the National Technical Information Service, concentrates on the technical grade of the active ingredient and identifies missing generic data. However, during the review of these'data we are also looking for potential hazards that may be associated with the end use (formulated) products that, p.ontain the active ingredient. If we have serious concerns, we will address end use products as part of the Registration Standards program and will propose regulatory actions to the extent necessary- to protect the public. EPA has the authority under FIFRA sec. 3(c)(2)(B) to require registrants to submit data that will answer our questions regarding the hazard that may result from the Intended use of a pesticide. Although sec. 3(c)(2)(B) provides that all registrants are responsible for these data, the Agency generally imposes generic data requirements only on the registrants of the manufacturing use products (basic suppliers ------- of the active ingredient) and other producers who do not qualify for the formulator's exemption.* A producer who wishes to qualify for the formulator's exemption may change his source of supply to a registered source, provided the source does not share ownership in common with the registrant's firm. A registrant may do so by submitting a new Confidential Statement of Formula, EPA Form 8570-4, identifying the registered source of the active ingredient, to the appropriate Product Manager within 90 days of receipt of this Guidance Document. The chart on the following page shows what is generally required of those who do ar.d do not qualify for the formulator's exemption in the Registration Standards program. If you decide to request the Agency to cancel the regis- tration of any of your products subject to the requirements of this Guidance Document, please notify the Product Manager named in the cover letter, within 90 days from the receipt of this document. If you decide to maintain your product registration(s), you must provide the information described in the following pages within the timeframes outlined. EPA will issue a notice of Intent to cancel or suspend the registration of any currently registered product which does not comply with the requirements set forth in this Guidance Document. You are reminded that FIFRA sec. 6(a)(2) requires you to submit factual Information raising concerns of possible unreasonable adverse effects of a pesticide. You should notify the Agency of interim results of studies in progress If those results show possible adverse effects. •The formulator's exemption applies to a registrant of an product if the source of his active ingredlent(s): (1) is a registered product and (2) is purchased from a source which does not have ownership in common with the registrant's firm. ------- PRODUCTS SUBJECT TO THE REGISTRATION STANDARDS PROGRAM ACTION(S) REQUIRED TO MAINTAIN REGISTRATION I. Products That Do Not Qualify For The Formulator's Exemption A. Single Active Ingredient Products* These products must be reregis- tered. To obtain reregistration, labeling, packaging and data requirements must be satisfied in accordance with the Regis- tration Standards Guidance Document. B. Multiple Active Ingredient Products These products will not be reregistered at this time. . However, generic data required to continue the registration of the active ingredient under review, as described in the Registration Standards Guidance Document, will be required and some labeling precautions may also be required. II. Products That Do Qualify For The Formulator1s Exemption Only when additional restric- tions or labeling are needed to protect man or the environment will these products be subject to the Registration Standard requirements. Affected products will be dealt with in a variety of ways, including but not limited to the Label Improvement Program and special intent to cancel notices. * End-use products of registrants who also produce a manufacturing- use product will not be required to be reregistered provided that registrant fulfills the requirements specified in the Guidance Document for manufacturing-use product(s). Such end-use products will be subject to the labeling changes required.for products in "II". above. If there are no manufacturing-use products registered by any company end-use products will be required to be reregistered. INOTE: If all registrants in "I" above fail to meet the requirements in JI-A and B above, then the registrants in "II" lose their right to (qualify for the formulator's exemption and become subject to the I requirements in I-A and B. ------- I. REGULATORY ASSESSMENT A. INTRODUCTION This Registration Standard describes the regulatory position and rationale of the Environnental Protection Agency (the "Agency") for all registered manufacturing- use products (MPs) containing sodium bentazon as the sole active ingredient.* This Standard also will require cetain changes on the labels of end-use products (EPs) containing sodium bentazon. The Agency bases its position and rationale on an evaluation of all MPs, and Section 3, 24(c), and Intrastate uses registered for sodium bentazon. After briefly describing the chemical and Its uses, this chapter presents the Agency's regulatory position and rationale, the criteria for registration, acceptable.ranges and limits, labeling requirements, and the current tolerances. B. IESCRIPTION OP CHEMICAL Bentazon Is the acceptable cannon name (approved by the Anerlcan National Standards Institute and the Weed Science Science Society of America) for the herbicide with the chemical name of 3-(l^thylethyl)-lH-2,l,3-benzothladiazln-4(3H)-one ' 2,2-dioxide. The Chemical Abstracts Service (CAS) Registry number for bentazon is 50723-80-3 while the EPA Office of Pesticide Program's Chemical Code Number • Is 275200. All products currently marketed In the U.S. contain the sodium salt of bentazon as the active Ingredient, referred to as', sodium bentazon. Sodium bentazon MP is marketed under the name "Bentazon Manufacturer's Concentrate". Sodium bentazon single active Ingredient EP is marketed under the name "Basagran* Postemergence Herbicide". A multiple active ingredient EP (mixture with atrazlne) is marketed under the name "Laddock" Postemergence Flowable Herbicide". The EPA Office of Pesticide Program's Chemical Code Number is 103901 for sodium bentazon. The chemical formula for bentazon is CioH^N^ChjS and the molecular weight is 240.3* Pure analytical standard (i.e., purer than technical) bentazon is ttoite. Technical grade bentazon (Isolated before formation of the sodium salt) Is an odorless, non-volatile solid with a melting point of 137-139°C. Its solubility (g/100 g solvent, 20°C) is 0.05 to water and 150.7 to acetone. Sodium bentazon is considerably more soluble to water than bentazon, with a solubility of 230 g/100 g to water. Sodium bentazon is a post-emergence contact herbicide used to control selected broadleaf weeds and sedges. It is applied by ground or air as a broadcast foliar spray following weed emergence. Various tank mixes are also permitted. See the EPA Index entry to this guidance package for additional label information, Including the use sites for viiich sodium bentazon is registered. C. Regulatory Position and Rationale T. The available data do not Indicate that any of the risk criteria listed to § 162.U (a) of Title 40 of, the U.S. Code of Federal Regulations have been met or exceeded for the uses of sodium bentazon at the present time. However, substantial data gaps exist. ------- Rationale: (Note: Agency data requirements for reregistration are described in 40 CFR Part 158. The data tables in this guidance package relate these specifically to bentazon and sodium bentazon.) Hunan/Domestic Animal Hazard Sodium bentazon belongs in Tbxlcity Category III (defined In 40 CFR 162.10) based upon acceptable acute oral and acute dennal data. An acute Inhalation study is supplementary (valid but does not meet EPA guideline requirements) and will need to be repeated. Subchronic data are supplementary (90-day rat feeding study and 13-week dog study; bentazon) or invalid (21-day dennal study; sodium bentazon), and will require.replacement. Compound-related effects were seen at 300 and 3000 ppm test levels in the dog study (numerous effects at 3000 ppm; prostatitis at 300 ppm was basis of lowest-effect-level of 300 ppm and no-effect-level of 100 ppm). A one year dog study is required for hazard assessment. All chronic toxiclty data for bentazon are supplementary or Invalid, and will require replacement. 24-month rat and 18-month mouse studies have been invalidated, and a "for cause" laboratory audit requested, due to substantial deficiencies. In a supplementary mouse oncogenlcity study, no specific clinical or pathological symptoms could be associated with bentazon exposure. A rat 3-generation reproduction study found no compound-related effects up to a dietary level of 180 ppm. However, without effects at the highest dose, the dose selection Is considered inadequate and an additional reproduction study is required. The available rat and rabbit teratogeniclty studies are Inadequate, but do not suggest that bentazon is a potent teratogen or fetotoxlc agent. Terata were observed In one rat study at a dose of 200 mg/kg/day, but the utility and validity of these data are In question. Additional teratology studies In the rat and rabbit are required. A variety of mutagenlcity studies (analytical grade bentazon; or sodium bentazon) have been reviewed, but none are adequate for regulatory purposes. This is also the case for metabolism studies with labeled bentazon. Ecological Effects Technical bentazon Is considered slightly toxic to birds based on subacute dietary testing. Formulated bentazon is considered slightly toxic to birds based on acute oral testing with a 50* a.i. wettable powder. Avian reproduction testing did not show effects up to the highest dietary level tested, but the studies were found to lack vital Information and do not presently meet EPA guideline requirements. Technical bentazon is characterized by EPA as practically nontoxic to both coldwater and wannwater fish, and slightly toxic to aquatic Invertebrates, based on review of acute testing. Formulated bentazon is considered practically nontoxic to coldwater and wannwater fish based on acute testing with a 48% a.i. liquid product. ------- Applications of sodium bentazon on registered use sites are considered unlikely to result in acute hazard to most nontarget organisms because of the generally low toxicIty seen In technical and formulated product testing, and low applicatl rates. However, a final risk assessment is deferred due to lack of critical environmental chemistry data and certain ecological effects data. Biological opinions (covering all registered pesticides) have been received from the U.S. Pish and Wildlife Service Office of Endangered Species (GES) for three of the crops for which sodium bentazon is registered: corn, sorghun, and soybeans. To avoid Jeopardy to the Valley Elderberry Longhorn Beetle (Desmoceru californlcus dlmorriius), OES indicates that herbicides should be prohibited iron designated areas In California In order to protect the host plant, elder- berry (Sambucus spp.). Labeling developed by EPA to Implement this prohibition Is Included in Section F below. These~opinions also stated that "...to avoid Jeopardy to Solano grass...the use of any herbicides toxic to graminoldes should be prohibited within..." certain defined geographic areas of California, because of concerns with spray drift and runoff from agricultural areas. Solano grass (Tuctorla (» Orcuttla) mucrohata.) Is an endangered plant species found In a vernal lakebedi in Solano County, California. Since no grass species are claimed on existing labeling " to be controlled with sodium bentazon and the herbicide Is used on various grass crops, Ecological Effects Branch (with Informal consultation with OES') did not consider there to be a threat to Solano grass frcm the registered use of this chemical.. Subsequently, information has been located indicating that sodium bentazon may affect certain geminating grass species with direct exposure at full dosage rates, but that It does not affect grasses after gennina Solano grass germinates in March and April. The earliest planting date for corn; sorghum, or soybeans Is for corn, which can be planted as early as April 1! Since sodium bentazon is applied postemergence to the weeds, there may be little opportunity for an application that could affect Solano grass. Further consultation with CES will be Initiated. Label restrictions, as above, and/or plant protection data requirements (under § 158.150) may be Imposed. An oyster study and further envlronnental chemistry data are required, in part, to evaluate whether there is any hazard to endangered mussel species frcm sodium bentazon use. ". • «« The Agency is not aware of any other data which would suggest that the risk criteria of § 162.11 have been met or exceeded for the uses of sodium bentazon at the present time. 2. The existing manufacturing-use pesticide product containing sodium bentazon as the sole active ingredient may continue to be registered for sale, distribution, reformulation, and use, subject to the terms and conditions specified In this Standard. The registrant must provide or agree to develop the additional data specified In Tables A and B of this guidance document to maintain the existing MP registration or to permit new registrations of substantially similar sodium bentazon MPs. •••'•'• •£*•••-•;•",•••• Rationale t There are substantial data gaps in support of existing sodium bentazon registra- tions. The Agency has discretion to cancel or deny registrations because data are missing or Inadequate. 'The Agency has elected to use the issuance of this Standard as the mechanism for Identifying data needs. The Agency will complete Its hazard evaluation, or determine what further data are necessary to do so, upon review of the data being called In under this Registration Standard. The Agency will determine at that time if such data will affect the registrations of bentazon. ------- If such review determines that criteria for determinations of unreasonable adverse effects are met or exceeded (as specified under §162.11), a rebuttable presumption shall arise that a notice of intent to cancel registration(s) pursuant to FIPRA §6(b)(l) (or a notice of Intent to hold a hearing to determine vtoether the registration(s) should be cancelled) may be issued. If, at any time, review of the data indicates that an Imminent hazard (as defined by FIFRA § 2(1)) is posed by bentazon use, Immediate suspension procedures may be Initiated as per FIFRA. §6(c)(l). 3. The term TGAI (technical grade of the active ingredient) In the data tables refers to the technical grade of bentazon, not sodium bentazon. On a case- by-case basis, testing using sodium bentazon may be acceptable for fulfilling TGAI testing requirements. Clarification or verification of all test materials used in studies submitted by the registrant is required. The Agency reserves the right to Impose additional testing of either bentazon or sodium bentazon following review of this information and/or review of new studies submitted to fulfill data gaps identified in this Standard. Rationale; Residue chemistry review has indicated that the moiety of concern (due to detectable residues) is bentazon, not sodiun bentazon, and thus all tolerances have been established for bentazon (combined with certain of its metabolites). It is possible that, in addition to testing with bentazon, further testing with sodium bentazon will be required to evaluate exposure specifically to sodium bentazon. In many cases, the test material used in studies submitted to the Agency is not fully identified, and it Is essential that this information be submitted to enable assessment. Note that, In addition to testing with TGAI, certain testing is specifically required using the MP (sodiun bentazon), PAI (bentazon pure active Ingredient), PAIRA (pure active Ingredient, radiolabelled} TEP (typical end-use product), and metabolites. 4 4. No new uses of sodiun bentazon will be permitted until the data base is adequate to complete a hazard assessment. Rationale; In accordance with Conditional Registration Interim Final Regulations (FR Vol. M, No. 93, May 11, 1979), no new uses or-new products may be registered without "data sufficient to allow the Agency to determine that approval of the application would not cause a significant Increase In the risk of unreasonable adverse effects on the environment". For bentazon/sodium bentazon, the entire subchronic and chronic toxicology data base (required to evaluate hazard to humans/donestic animals from existing uses) is invalid or otherwise Inadequate, and thus totally insufficient for evaluation of any new uses. The Agency is unable to complete a tolerance reassessment of bentazon/sodium bentazon because of these gaps, as well as residue chemistry data gaps. The Agency is unable to fully assess potential human exposure, potential for groundwater contamination, or conplete an ecological effects hazard assessment of existing sodium bentazon uses because of exposure assessment/environmental chemistry data gaps. There are also certain product chemistry," wildlife/aquatic organism, and nontarget Insect data gaps that prevent full assessment of existing use. ------- 5- The MP and EP manufacturer must make labeling changes specified in this guidance document. These include grazing restrictions, a rotational crop restriction, prohibition of sodium bentazon use where commercial crayfish or catfish fanning are practiced, and restrictions regarding use of bentazon- or sodium bentazon-contamlnated water for irrigation. Rationale; Residue chemistry review indicates a need for grazing restrictions for corn and peanut forage to ensure residues are below established tolerance levels of 3 ppm for these forage items at the tine of grazing. To complete an exposure assessment, rotational .crop data, residue data on crops receiving'irrigation water from sodium bentazon-treated rice fields, and residue data on crayfish and catfish that are fanned in rice fields are among the data required. Fending submission and review of this data, the cited restrictions are required. Ecological effects review specifies the modified/updated environmental hazard statements as per Proposed Rule 40 CPR §156.55: Federal Register Vol. 49, No. If September 26, 1984. 6. Based on review of available data, bentazon itself is not considered likely to contaminate groundwater. However, data are required to determine the potential for bentazon metabolites to contaminate groundwater. Bentazon does have the potential to contaminate surface waters. Rationale; Review indicates that bentazon is very mobile In soil but that rapid degradation is likely to prevent groundwater contamination. An aged leaching study is needed to determine the potential for metabolites to contaminate groundwater. Bentazon has the potential to contaminate surface waters because of 1) its rice use pattern that Involves either direct application to water or application to fields prior to flooding, and 2) runoff from treated areas for other uses. D. CRITERIA FOR REGISTRATION UNDER THE STANDARD To be covered under this Standard, products must contain sodium bentazon as the sole active Ingredient, bear required labeling, and conform to the product composition, acute toxicity limits, and use pattern requirements listed in Section E of this document. She applicant for registration or rereglstration of manufacturing-use products subject to this Standard must comply with all terms and conditions described In it, Including submission of an up-to-date Confidential Statement of Formula, sutmisslon of revised labeling, comnitment to fill data gaps on the schedule specified by the Agency and, when applicable, off er to pay compensation as required by 3(c)(l)(D) and 3(c)(2)(D) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended, 7 U.S.C. 136(c)(l)(D) and 136(C)(2)(D). Registration applicants must contact the Agency for specific Instructions, including updated information on data requirements and companies whose data have been used In support of registration. 8 ------- Registrants of end-use products who do not qualify for the flormulator's Exanption must satisfy labeling, packaging, and data requirements In accordance with this guidance package. Registrants of end-use products who qualify for the Formula tor's Exanption must conply with the unique labeling statements identified in Section P. E. ACCEPTABLE RANGES AND LIMITS 1. Product Composition Standard To be covered under this Standard, manufacturing-use products must contain sodium bentazon as the sole active ingredient. Each MP formulation proposed for registration must be fully described with an appropriate certification of limits, stating maximum and minimum amounts of the active Ingredient which may be present In products. 2. Acute Toxiclty Limits The Agency will consider registration of manufacturing-use products containing sodium bentazon, provided that the product labeling bears appropriate precautionary statements for the acute toxicity category in which each product is placed. 3. Use Patterns To be registered under this Standard, manufacturing-use products containing sodium bentazon may be labeled for formulation into end-use products only for the ccranodities listed below. The attached Index entry lists all registered uses, as well as approved maximum application rates and frequencies. -Terrestrial, non-donestlc, food uses: beans (dry or succulent), Bohemian chili peppers, corn (field, sweet, or popcorn), grain sorghum, peanuts, peas (dry or succulent), peppermint, soybeans, speannint. -Aquatic, non-dcmestic, food use: rice -Terrestrial, non-domestic, non-food juse: established ornamental turf (bahiagrass, bentgrass, bermudagrass, bluegrass, centlpedegrass fescue, ryegrass-, St. AugustInegrass, zoysiagrass) -Terrestrial, domestic, non-food use: established ornamental turf species listed above. LABELING All MPs and EPs containing sodium bentazon must bear appropriate labeling as specified In HO CFR §162.10. The guidance package for this Standard contains Information on label requirements. All labeling changes must appear on all products released for shipment by 9/86. All labeling changes must appear on all products in channels of trade by 9/87. ------- In addition, the following restrictions are required: 1. Manufacturing-Use Products a) When citing the bentazon equivalent, the chemical name for bentazon should be written as M3-(lHnethylethyl)-lH-2,l,3-benzothiadiazin-4(3H)- one 2,2 dioxide11. b) "Do not discharge effluent containing this product into lakes, streams, ponds, estuaries,- oceans, or public waters unless this product is specifically identified and addressed In a National Pollutant Discharge Elimination System (NPDES) penult. Do not discharge effluent containing this product to. sewer systems without previously notifying the sewage treatment plant authority. For guidance, contact your State Water Board or Regional Office of the U.S. Environmental Protection Agency." 2. End-Use Products a) "Do not graze treated corn fields for at least 12 days after the last sodium bentazon treatment.1* b) "Do not graze treated peanut fields for at least 50 days after the - last sodium bentazon treatment." c) "Do not rotate crops used for food or feed, which are not registered for use with sodium bentazon, on areas previously treated with this chemical." d) "Do not use sodium bentazon on rice fields In which the commercial cultivation of catfish or crayfish Is practiced." e) "Do not use water containing bentazon or sodium bentazon residues from rice cultivation to irrigate crops used for food or feed unless sodium bentazon is registered-for use on these crops." f) For all uses except rice: "Do not apply directly to water or wetlands. Do not contaminate' water by cleaning of equipment or disposal of wastes. g) ' For rice use: "Do not contaminate water by cleaning of equipment or disposal of wastes." h) "Notice; It is a violation of federal laws to use any pesticide In a manner that results In the death of an endangered species or adverse modification of their habitat. » "The use of this product may pose a hazard to certain federally designated endangered species known to occur In specific areas within the CALIFORNIA counties of Merced, Sacramento, and Solano. Before using this product in these counties you must obtain the EPA Endangered Species Bulletin specific for these areas. The bulletin (EPA/ES-85-8) is available from either your County, Agricultural Extension Agent, the Endangered Species Specialist In your State Wildlife Agency Headquarters, or the Regional Office of the U.S. Fish and Wildlife Service (Portland, Oregon). THIS BULLETIN MUST BE REVIEWED PRIOR TO PESTICIDE; USE. THE USE OP THIS PRODUCT IS PROHIBITED IN THESE COUNTIES UNLESS SPECIFIED OTHERWISE IN THE BULLETIN." 10 ------- 1) Where bentazon equivalent is cited on the label, the chemical name should be as in 1 (a) above. TOLERANCES m the IMited States, tolerances are currently established in 40 CPR §180.355 for a) combined residues of bentazon (3-isopropyl-lH-2,l,3-benzothladlazln-4(3H)- one-2,2-dioxide) and its 6- and 8-hydroxy metabolites in or on agricultural commodities as follows: Commodity parts per million Beans (except soybeans), dried 0.05 Beans (exc. soybeans), dried, vine hays 3 Beans (exc. soybeans), forage 3 Beans, lima (succulent) 0.05 Beans, succulent 0.5 Bohemian chili peppers 0.5* Com, fodder 3 Corn, forage 3 Corn, grain 0.05 Corn, fresh (incl. sweet K-KJWHR) 0.05 Mint 1 Peanuts 0.05 Peanuts, hay 3 Peanuts, hulls 0.3 Peanuts, forage 3 Peas (dried) 0.05 Peas (dried), vine hays 3 Peas, forage 3 Peas, succulent 0.5 Rice 0.05 Rice, straw 3 Sorghum, fodder 0.05 Sorghum, forage 0.20 Sorghum, grain 0.05 Soybeans 0.05 Soybeans, forage 3 Soybeans, hay 0.3 and b) combined residues of bentazon (3-isopropyl-lH-2,l,3-benzothiadiazin-M(3H)- one-2,2-dioxide) and its metabolite 2-amino-N-isopropyl benzamide in raw agricultural commodities as follows: Commodity Parts per million Cattle, fat 0.05 Cattle, mbyp 0.05 Cattle, meat 0.05 Eggs °'°5 Goats, fat 0.05 Goats, mbyp 0.05 Goats, meat 0.05 11 ------- (cont.) Commodity parts per million Hogs, fat 0.05 Hogs, mbyp 0.05 Hogs, meat 0.05 Milk 0.02 Poultry, fat 0.05 Poultry, mbyp 0.05 Poultry, meat 0.05 Sheep, fat 0.05 Sheep, mbyp 0.05 Sheep, meat 0.05 •The misprinted tolerance of 0.5 ppn for Bohemian chill peppers will be corrected to read 0.05 ppm. Tolerance reassessment cannot be conducted because of toxicology and residue chemistry data gaps. International Tolerances There are 0.1 ppm Canadian tolerances for bentazon on soybeans, beans, peas, corn, rice, and peanuts. Presently, there are no Mexican or Codex Allmentarius tolerances for bentazon. 12 ------- EPA Compendium of Acceptable Uses BENTAZON, SODIUM SALT* TYPE PESTICIDE; Herbicide FORMULATIONS; Tech (462) F1C (1.66 Ib/gal) SC/L (4 Ib/gal) GENERAL WARNINGS AND LIMITATIONS; A selective herbicide for postemergence control of certain broadleaf weeds and sedges* It is effective mainly through contact action and foliar absorption. Rainfall or overhead irri- gation within 8 hours after application may nullify its effectiveness. Apply in 20 to 50 gallons of water per acre at 40 to 80 psi of pressure with ground equipment; the higher rates are for use in dense crop or weed foliage. Use a minimum of 5 gallons of water per acre and a maximum of 40 psi of pressure with aerial applications. Do not use flood, whirl chamber, or controlled droplet applicator (CDA) nozzles. Do not cultivate within 5 days before or after application in the following northern and western states: AZ, CA, CO, CT, ID, IL, IN, IA, KS, KY, ME, MA, MI, MM, MO, MT, NB, NV, NH, NJ, NY, ND, OH, OR, PA, RI, SD, UT, VT, WA, WV, WI, WY. Do not apply to crops that have been subjected to stress conditions such as hail damage, flooding, drought, injury from other herbicides, or widely fluctuating temperatures, as crop injury may result. It may be necessary to irrigate prior to application to ensure active weed growth; weeds growing under drought conditions are usually not satisfactorily con- trolled. TIME REQUIRED FOR CONTROL; Not located. PHYTOTOXICITY TO TARGET WEEDS; Not located. PHYTOTOXICITY TO CROPS; Some leaf-speckling and leaf-bronzing may occur under certain conditions. MODE OF ACTION; Inhibition of 'photosynthesis and particularly, the Hill reaction. Livestock Tolerances; 0.02 ppm in milk; 0.05 ppm in eggs and in meat, fat and meat byproducts of cattle, goats, hogs, poultry and sheep. BROADLEAF WEEDS CONTROLLED; Balloonvine (a)(c) Bristly starbur (a)(c)(d) Canada thistle (a)(b)(d)(f)(g) Coffee senna (a)(c) Common cocklebur (a)(c)(d)(e)(f)(g) Common groundsel (b) *Bentazon 3-isopropyl-lH-2,l,3-benzothiadiazin-4(3H)-one 2,2-dioxide (sodium salt) Basagran Issued: 6-28-85 1-103901-1 13 ------- EPA Compendium of Acceptable Uses BENTAZON, SODIUM SALT BROADLEAF WEEDS CONTROLLED (continued) PBDAEBA Common lambsquarters PEDADBA Common purslane PBFAEBA Common ragweed PBFBUBA Common sunflower PBGAFBM Cypressvine morningglory PBEABAA Dayflower PBFAOBE Devils beggarticks PBGAFBV Entireleaf morningglory PBGACBB Field bindweed PBFBOAA Galinsoga PBFAEBE Giant ragweed PAUAEBA Gooseweed PEWAIBG Hairy nightshade PBGACBD Hedge bindweed PCQBSBB Hemp sesbania PBGAFBG Ivyleaf morningglory PEWADBD Jimsonweed PBDAIBA Kochia PEAAGBP Ladysthumb PBGAFBS Palmleaf morningglory PEAAGBO Pennsylvania smartweed PBGAFBU Pitted morningglory PDAAJBF Prickly sida PBGAFBT Purple morningglory PCYABBA Redstern PEYABBA Redweed PBFDKAA Salsify PBKAHBA Sheperdspurse PBGAGBB Smallflower morningglory PEAAGAD Smartweed PDAACBA Spurred anoda PBGAFBL ;, Tall morningglory PBVAEBB Tropic croton PDCABBA Unicorn-plant PDAABBB Velvetleaf PDAAEBC Venice mallow PBFDBBF Western goldenrod PEAAGBH Wild buckwheat PBKBKBB Wild mustard PBVAGBU Wild poinsettia (a) in soybeans (b) in mints (c) in peanuts (d) in corn and grain sorghum (e) in rice (f) in beans (g) in peas (aXcHd) (a)(c)(dXe) (aXcXd) (aXcXd) (aXdXf) (aXdXf) UXcXdXfXg) (e) CbXfXg) (aXd)(f) (a) (aXc) (aXc)(dXfXg) (b) CaXbXdXfXg) (aXcXd) CaXbXcXdXfXg) (aXc)(d) (aXcXdXfXg) (aXcXd) (e) (aXe) (b) (aXfXg) (aXcXd) (e) (aXcXd) (aXcXd) (a).(cXd) (aXcXf) UXcXdXf) (aXd) (b) (aXd) (aXbXdXfXg) (a) Issued: 6-28-85 1-103901-2 14 ------- EPA Compendium of Acceptable Uses BENTAZON, SODIUM SALT GRASSES AND OTHER MONOCOTS CONTROLLED: PBMAEBH Largespiked spikerush PBMADBI Yellow nutsedge (e) (a) in soybeans (b) in mints (c) in peanuts (d) in corn and grain sorghum (e) in rice (f) in beans (h) in ornamental turf AQUATIC WEEDS CONTROLLED: PAEABBB Common waterplantain PECACBB Ducksalad PBMAGBG Ricefield bulrush PBMAGBF River bulrush PAEADAA Sagittaria PBMADBF SmalIflower umbrella sedge (e) (e) (i) (i) (e) (i) (e) (i) in rice in CA rice Issued: 6-28-85 1-103901-3 15 ------- Site, Dosage and Formulation (Ib a.i./A) EPA Compendium of Acceptable Uses BENTAZON, SODIUM SALT Tolerance, Use, Limitations 15001AA 15002AA 15003AA TERRESTRIAL FOOD CROP (Agricultural Crops) Beans, Dry or Succu- lent 0.75-1.0 (4 Ib/gal SC/L) 1.0-1.5 (4 Ib/gal SC/L) 0.05 ppm (beans, dry) 0.05 ppm (beans, lima (succulent)) 0.5 ppm (beans, succulent) 3.0 ppm (beans, dry, vinehay) 3.0 ppm (beans, forage) 30 day preharvest interval in succulent beans. Do not apply more than 2 pounds active ingredient per acre in one season. General Information; Do not apply to bean fields until beans have at least the first trifoliate leaf fully expanded because severe crop damage may occur. Tolerant bean types are navy, pinto, pinks, great northern, kidney, red, whites, cran- berry, black turtle soup, small limas, large limas, and snap beans. Postemergence. Broadcast. Apply when weeds are small and actively growing. Certain weed problems may require the use of the higher dosage and re- peat treatments, or the use of an oil concentrate. The addition of oil may increase crop injury and reduce yields. Use limited to IL, IN, KY, MI, and OH. Postemer- gence. Broadcast. For suppression of field and hedge'bindweed. Apply with an oil concentrate when the bindweed vines are a maximum of 10 inches long. Issued: 6-28-85 1-103901-4 16 ------- 28005AA Site, Dosage and Formulation (Ib a.i./A) Corn 0.75-1.0 (4 Ib/gal SC/L) EPA Compendium of Acceptable Uses BENTAZON, SODIUM SALT Tolerance. Use. Limitations 0.05 ppm (grain) 0.05 ppm (fresh corn (including sweet corn kernel plus cob with husk removed)) 3.0 ppm (fodder and forage) Do not apply more than 2 pounds active ingredient per acre in 1 season. General Information; Corn is tolerant at all stages of growth, but applications generally cor- respond to the corn growth stages of 1 to 5 leaves. Seed corn producers should consult toler- ance of seed production inbred lines to bentazon. Postemergence. Broadcast. Apply when weeds are small and actively growing. Certain weed problems may require the use of the higher dosage and re- peat treatments, or the use of an oil concentrate. 0.50-0.75 (1.66 Ib/gal F1C) (4 Ib/gal SC/L) 1.0-1.5 (4 Ib/gal SC/L) 1.0-1.5 (4 Ib/gal SC/L) 1.0-1.5 (4 Ib/gal SC/L) Postemergence. Broadcast. Apply when weeds are small and actively growing-. Do not'make more than 1 application per season. Oil concentrate must be added to the spray mixture. Formulated with or tank mixed with atrazine. Use limited to all other than the following south- ern states: AL, AR, FL, GA, LA, MS, NC, OK, SC, TN, TX, VA. Postemergence. For partial control of annual morningglories not larger than 4 true leaves. Apply with an oil concentrate. Use limited to IL, IN, KY, MI, and OH. Postemer- gence. Broadcast.- For suppression of field and hedge bindweed. Apply with an oil concentrate when the bindweed vines are a maximum of 10 inches long. Postemergence. Broadcast. To provide partial control of cocklebur where earlier treatments were either not made or not successful. Use a thorough spray coverage of cocklebur plants up to 24 inches tall. Make a single application as shown, or ap- ply 0.75 pound active ingredient per acre and re- peat 10 to 14 days later. Issued: 6-28-85 1-103901-5 17 ------- '28015AA Site, Dosage and Formulation (Ib a.i./A) Peanuts 0.75-1.0 (4 Ib/gal SC/L) liO-1.5 (4 Ib/gal SC/L) EPA Compendium of Acceptable Uses BENTAZON, SODIUM SALT Tolerance. Use. Limitations 0.05 ppm (peanuts) 0.3 ppm (hulls) 3.0 ppm (forage and hay) Do not apply more than 2 pounds active ingredient per acre in 1 season. General Information; Peanuts are tolerant at all stages of growth, but applications generally cor- respond to the peanut growth stages of bunching to pegging. Postemergence. Broadcast. Apply when weeds are small and actively growing. Certain weed problems may require the use of the higher dosage or repeat treatments, or the use of an oil concentrate. May be tank mixed with 4-(2,4-dichlorophenoxy)- butyric acid, dimethylamine salt for postemergence control of morningglories; or with acifluorfen (except in OK and TX). Postemergence. Broadcast. To provide partial control of cocklebur where earlier treatments were either not made or not successful, use a thorough spray coverage of cocklebur plants up to 24 inches tall. Make a single application, or apply 0.75 pound active ingredient per acre and repeat 10 to 14 days later. /28074AA Peas (dry or succu- lent) 0.75-1.0 (4 Ib/gal SC/L) 0.05 ppm (peas, dry) 0.5 ppm (peas, succulent) 3.0 pptn (peas, dry, vinehay) 3.0 ppm (peas, forage) Do not apply more than 2 pounds active ingredient per acre in 1 season. General Information; Peas are tolerant to benta- zon after 3 pairs or leaves (or 4 nodes) are pre- sent. Tolerant pea types are garden peas and southern peas. Do not use on blackeyes grown in CA or to garbanzo beans at any stage of growth, as severe crop damage will occur. Do not add oil to any bentazon application to peas. Postemergence. Broadcast. Apply when weeds are small and actively growing. Certain weed problems may require the use of the higher dosage and re- peat treatments. Issued: 6-28-85 1-103901-6 18 ------- Site, Dosage and Formulation (Ib a.i./A) /28012AA Peppermint Spearmint 1.0-2.0 (4 Ib/gal SC/L) /28072AA Rice 0.75-1.0 (4 Ib/gal SC/L) 0.75 (4 Ib/gal SC/L) EPA Compendium of Acceptable Uses BENTAZON, SODIUM SALT Tolerance, Use, Limitations 1 ppm (mint) Do not apply more than 4 pounds active ingredient per acre in 1 season. Broadcast to established crops when weeds are small and actively growing. Certain weed problems may require the use of the higher dosage and re- peat treatments, or the use of an oil concentrate. 0.05 ppm (rice) 3.0 ppm (straw) Do not apply more than 3 pounds active ingredient per acre in 1 season (maximum of 2 pounds active ingredient per acre in first crop and 1 pound ac- tive ingredient per acre in second ratoon crop). General Information; Do not apply with ground equipment when field is flooded because splashing will wash the chemical off weed leaf surfaces and minimize control. When making aerial applica- tions, orient all nozzles straight down. Bentazon may be used on the first and second (ratoon) crop. Early postemergence. Broadcast. In an alternate flooding culture, apply when there is not water on the field and at least 24 hours prior to flood- ing. The weed growth stages at this time general- ly correspond to*rice that is tillering (stool- ing). In a continuous flooding culture or when treating after permanent flood, apply when weeds are above the surface of the water. For early treatment, water may be partly or completely drained to expose more w,eed growth. Do not raise water level for at least 24 hours after applica- tion. In CA add nonphytotoxic oil (containing emulsifier) to the spray mixture. Postemergence. Tank mix with 3* ,4'dichloropro- pionanilide for control of mixed populations of grasses and broadleaf weeds. Apply by ground or air to drained fields only. Do not apply on the second (ratoon) crop. Issued: 6-28-85 1-103901-7 19 ------- '28019AA Site, Dosage and Formulation (Ib a.i./A) Sorghum, Grain '28023AA 0.75-1.0 (4 Ib/gal SC/L) 0.5-0.75 (4 Ib/gal SC/L) Soybeans 0.75-1.0 (4 Ib/gal SC/L) 1.0-1.5 (4 Ib/gal SC/L) EPA Compendium of Acceptable Uses BENTAZON, SODIUM SALT Tolerance. Use. Limitations 0.05 ppm (grain, fodder) 0.2 ppm (forage) Do not apply more than 1 pound active ingredient per acre in 1 season. Do not apply to grain sorghum that is heading or blooming. General Information; Grain sorghum is tolerant at all stages of growth up to and including early boot stage, but applications generally correspond to the crop growth stages of 1 to 5 leaves. Posternergenee. Broadcast. Apply when weeds are small and actively growing. Certain weed probleas may require the use of the higher dosage or the addition of an oil concentrate. Postemergence. Broadcast. Apply when weeds are small and actively growing. Do not make more than 1 application per season. An oil concentrate must be added to the spray mixture. Tank mix with atrazine. 0.05 ppm (soybeans) 0.3 ppm (hay) 3.0 ppm (forage) Do not apply more than 2 pounds active ingredient per acre in 1 season. General Information; Soybeans are tolerant to bentazon at all stages of growth, but applications generally correspond to the growth stages of uni- foliate to 2 expanded trifoliate leaves. May be tank mixed with, or applied sequentially to sethoxydim; or aciflubrfen, or sethoxydim and acifluorfen. The determination of tank mix or sequential application should be made by the stage of the weeds being controlled by each chemical. Postemergence. Broadcast. Apply when weeds are small and actively growing. Certain weed problems may require the use of the higher dosage and re- peat treatments, or the use of an oil concentrate. Use limited to all other than the following south- ern states: AL, AR, FL, GA, LA, MS, NC, OK, SC, TN, TX, VA. Postemergence. For partial'control of annual momingglories not larger than 4 true leaves. Apply with an oil concentrate. Issued: 6-28-85 1-103901-8 20 ------- Site, Dosage and Formulation (Ib a.i./A) EPA Compendium of Acceptable Uses BENTAZON, SODIUM SALT Tolerance, Use, Limitations Soybeans (continued) 1.0-1.5 (4 Ib/gal SC/L) 1.0-1.5 (4 Ib/gal SC/L) 0.75-1.0 (4 Ib/gal SC/L) Spearmint Use limited to IL, IN, KY, MI, and OH. Postemer- gence. Broadcast. For suppression of field and hedge bindweed. Apply with an oil concentrate when the bindweed vines are a maximum of 10 inches long. Postemergence. Broadcast. To provide partial control of cocklebur where earlier treatments were either not made or not successful, use a thorough spray coverage of cocklebur plants up to 24 inches tall. Make a single application, or apply 0.75 pound active ingredient per acre and repeat 10 to 14 days later. Postemergence. Broadcast. Tank mix with 4-(2,4- dichlorophenoxy)butyric acid, dimethylamine salt for postemergence control of morningglories. Ap- ply when weeds are actively growing and before annual morningg lory vines are a maximum of 6 inch- es long in the south (AL, AR, FL, GA, LA, MS, NC, OK, SC, TN, TX, VA) and a maximum of 10 inches long in all other states. Do not add oil to the tank mix. Do not make more than 1 application of the tank mix per season. See Peppermint cluster. '33015AA '33016AA '33017AA '33019AA '33023AA '33031AA '33049AA '33050AA '33056AA TERRESTRIAL NON-FOOD CROP (Ornamental Plants and Forest Trees) Bahiagrass Bentgrass Bermudagrass Bluegrass Centipedegrass Fescue Ryegrass St. Augustinegrass Zoysia Grass 1.0-2.0 (4 Ib/gal SC/L) Issued: 6-28-85 Broadcast. Yellow nutsedge control. Apply to es- tablished turf when yellow nutsedge is actively growing under good soil moisture conditions. If desired control is not obtained with the first ap- plication, make additional applications at inter- 1-103901-9 21 ------- EPA Compendium of Acceptable Uses BENTAZON, SODIUM SALT Site, Dosage Tolerance, Use, Limitations and Formulation (Ib a.i./A) Bahiagrass cluster (continued) vals of 10 to 14 days. Do not apply more than 3 pounds active ingredient per acre in any 1 sea- son* Flan the initial application for when most yellow nutsedge has emerged. In unmowed turf, make first application after yellow nutsedge emer- gence but before it is 8 inches tall. Do not mow 3 to 5 days before or after application. Do not apply to golf course greens or collars. Avoid over-the-top spraying of adjacent ornamentals. Spraying near the base of established ornamentals should not result in injury. AERIAL AND TANK MIX APPLICATIONS 9001500 Aerial Application aAAAAAA Refer to TERRESTRIAL FOOD CROP (Agricultural Crops) All Sites 9900300 Tank Mix aAAAAAA — Refer to TERRESTRIAL FOOD CROP (Agricultural Crops) Corn, Peanuts, Rice, Sorghum. Soybeans Issued: 6-28-85 1-103901-10 22 ------- EPA Compendium of Acceptable Uses BENTAZON, SODIUM SALT Listing of Registered Pesticide Products by Formulation i046.0001 46% technical chemical bentazon, sodium salt (103901) 007969-00042 ilOl.6614 1.66 Ib/gal flovable concentrate bentazon, sodium salt (103901) pLus atrazine (080803) 007969-00054 i!04.0015 4 Ib/gal soluble concentrate/liquid bentazon, sodium salt (103901)- 007969-00045 Issued: 6-28-85 1-103901-11 23 ------- EPA Compendium of Acceptable Uses BENTAZON, SODIUM SALT Appendix A Listing of Common Chemical Names Used on the Entry Chemical Common Name . EPA Acceptable Code (source) Common/Chemic al~Name 121001 sethoxydim (ISO) 2-[l-(ethoxyimino)butyl]-5-[2-(ethylthio)- propyl]-3-hydroxy-2-cyclohexen-l-one Issued: 6-28-85 1-103901-12 24 ------- 'EQABBA 'BFABBB 'BFAWBB 'CQAMBG 'BFDQBD ?BFCXBK 'BDAEBA >EDADBA 'BFAEBA 'BFBUBA 'BGAFBM 'BEABAA 'BFAOBE 'BGAFBV 'BGACBB 'BFBOAA 'BFAEBE 'AUAEBA >EWAIBG 'BGACBD ttQBSBB 'BGAFBG 'EWADBD 'BDAIBA 'EAAGBP 'BGAFBS ?EAAGBO 'BGAFBU 'DAAJBF ?BGAFBT 'CYABBA 5EYABBA ?BFDKAA ?BKAHBA PBGAGBB PEAAGAD ?DAACBA PBGAFBL ?BVA£BB PDCABBA PDAABBB PDAAEBC PBFDBBF PEAAGBH PBKBKBB ?BVAGBU EPA Compendium of Acceptable Uses BENTAZON, SODIUM SALT Appendix B Listing by Site/Pest and Site/Formulation/Registration Number BROADLEAF WEEDS CONTROLLED: Balloonvine Bristly starbur Canada thistle Coffee senna Common cocklebur Common groundsel Common lambsquarters Common purslane Common ragweed Common sunflower Cypressvine morningglory Dayflower Devils beggarticks Entireleaf morningglory Field bindweed Galinsoga Giant ragweed Gooseweed Hairy nightshade Hedge bindweed Hemp sesbania Ivyleaf morninglory Jimsonweed Kochia Ladysthumb Palmleaf morningglory Pennsylvania smartweed Pitted morningglory Prickly sida Purple morningglory Redstem Redweed Salsify Sheperdspurse SmalIflower morningglory Smartweed Spurred anoda Tall morningglory Tropic croton Unicorn-plant Velvetleaf Venice mallow Western goldenrod Wild buckwheat Wild mustard Wild poinsettia Issued: 6-28-85 1-103901-13 25 ------- ?BMAEBH PBMADBI EPA Compendium of Acceptable Uses BENTAZON, SODIUM SALT Appendix B Listing by Site/Pest and Site/Formulation/Registration Number (continued) GRASSES AND OTHER MONOCOTS CONTROLLED; Largespiked spikerush Yellow nutsedge AQUATIC WEEDS CONTROLLED; PAEABBB Common vaterplantain PECACBB Ducksalad ?BMAGBG RicefieId bulrush ?BMAGBF River bulrush PAEADAA Sagittaria PBMADBF Smallflower umbrella sedge /15001AA /15002AA /15003AA /28005AA /28015AA /28074AA TERRESTRIAL FOOD CROP (Agricultural Crops) Beans, Dry or Succulent Pest (see lists above) (4 Ib/gal SC/L) 007969-00045 Corn Pest (see lists above) (1.66 Ib/gal F1C) 007969-00054 (4 Ib/gal SC/L) 007969-00045 Peanuts Pest (see lists above) (4 Ib/gal SC/L) 007969-00045 Peas (dry or succulent) Pest (see lists above) (4 Ib/gal SC/L) 007969-00045 Issued: 6-28-85 1-103901-14 26 ------- EPA Compendium of Acceptable Uses BENTAZON, SODIUM SALT Appendix B Listing by Site/Pest and Site/Formulation/Registration Number (continued) /28012AA Peppermint Spearmint Pest (see lists above) (4 Ib/gal SC/L) 007969-00045 .'2807 2AA Rice Pest (see lists above) (4 Ib/gal SC/L) 007969-00045 '28019AA Sorghum, Grain Pest (see lists above) (4 Ib/gal SC/L) 007969-00045 '28023AA Soybeans Pest (see lists above) (4 Ib/gal SC/L) 007969-00045 TERRESTRIAL NON-FOOD CROP (Ornamental Plants and Forest Trees) '33015AA Bahiagrass Pest (see lists above) (4 Ib/gal SC/L) 007969-00045 '33016AA Bentgrass Pest (see lists above) (4 Ib/gal SC/L) 007969-00045 • '33017AA Bermudagrass Pest (see lists above) (4 Ib/gal SC/L) 007969-00045 '33019AA Bluegrass Pest (see lists above) (4 Ib/gal SC/L) 007969-00045 Issued: 6-28-85 1-103901-15 27 ------- EPA Compendium of Acceptable Uses BENTA20N, SODIUM SALT Appendix B Listing by Site/Pest and Site/Formulation/Registration Number (continued) '33023AA Centipedegrass Pest (see lists above) (4 Ib/gal SC/L) 007969-00045 '33031AA Fescue Pest (see lists above) (4 Ib/gal SC/L) 007969-00045 33049AA Ryegrass Pest (see lists above) (4 Ib/gal SC/L) 007969-00045 33050AA St. Augustinegrass Pest (see lists above) (4 Ib/gal SC/L) 007969-00045 33056AA Zoysia Grass Pest (see lists above) (4 Ib/gal SC/L) 007969-00045 Issued: 6-28-85 1-103901-16 28 ------- REQUIREMENT FOR SUBMISSION OF GENERIC DATA A. This portion of the guidance document is a Notice issued under the authority of PIPRA sec. 3(c)(2)(B). The tables following this section list the data required for maintaining the registrability of each product. EPA has determined that additional generic data described in Table A must be submitted to EPA for evaluation in order to maintain in effect the registration(s) of your product(s) identified as an attachment to the cover letter accompanying this guidance document. As required by PIPRA sec. 3(c)(2)(B), you are required to take appropriate steps to comply with this Notice. . EPA may suspend the registration of each of those products unless, within the specified time, you have informed EPA how you will satisfy the requirements of this Notice. Any such suspension will remain in effect until you have complied with the terms of this Notice. B. What Generic Datal/ Must be Submitted. You may deter- mine which generic data you must submit by consulting Table A at the end of this chapter. That table lists the generic data needed to evaluate the continued registrability of all products, and the dates by which the data must be submitted. The required studies must be conducted in accordance with EPA approved protocols (such as those contained in the Pesticide Assessment Guidelines 2/ or data collected under the approved protocols of the Organization for Economic Cooperation and Development (OECD). If you do not wish to develop data in support of certain uses appearing in your labeling, you may delete those uses at the time you submit your revised labeling. ^ For certain kinds of testing (generally ecological effects), EPA requires the test substance .to be a "typical formulation," and in those cases EPA needs data of that type I/ Generic data pertain to the properties or effects of a particular Ingredient, and thus are relevant to an evaluation of the risks of all products containing that ingredient, regardless of the product's unique composition or specific use. Product- specific data relate only to the properties or effects of a product with a particular composition (or a group of products with closely similar composition). 2/ The Pesticide Assessment Guidelines are available-in hard copy or microfiche from the National Technical Information Service, 5285 Port Royal Road, Springfield, Va. 22161. 29 ------- for each major formulation category (e.g., emulsifiable concen- trates, wettable powders, granulars, etc.) These are classified as generic data and when needed are specified in Table A. EPA ir.ay possess data on certain "typical formulations" but not others. Note; "Typical formulation" data should not be confused with product-specific data (Table B) which are required on each formulation. Product-specific data are further explained in Chapter III of this document. C. Options Available for Complying With Requirements to Submit Data Within 90 days of your receipt of this' Notice you must 'submit to EPA a completed copy of the form entitled "PIPRA Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix 11-33 for each of your products. On that form you must state which of the following methods you will use to comply with the requirements of this Notice: 1. (a) Notify EPA that you will submit the data, and (b) either submit the existing data you believe will satisfy the requirement, or state that you will generate the data by conducting testing. If the test procedures you will use deviate from (or are not specified in) the Pesticide Assessment Guidelines or protocols contained in the Reports of Expert Groups to the Chemicals Group, Organization for Economic Cooperation and Development (OECD) Chemicals Testing Programme, you must enclose the protocols you will use. OR 2. Notify EPA that you have entered Into an agreement with one or more other registrants to Jointly develop (or share in the cost of developing) the data. If you elect this option, you must notify EPA-which registrant(s) are parties to the agreement. OR 3. Pile with EPA a completed "Certification of Attempt to Enter Into an Agreement With Other Registrants for Develop- ment of Data" (EPA Form 8580-6, Appendix II-4)*/ V PIPRA sec. 3(c)(2)(B) authorizes Joint development of data by two or more registrants, and provides a mechanism by which parties can obtain an arbitrator's decision if they agree to Jointly develop data but fail to agree on all the terms of the agreement. The statute does not compel any registrant to agree to develop data Jointly. (Footnote continued on next page) 30 ------- OR b. Request that EPA amend your registration by deleting the uses for which the data are needed. (This option is not available to applicants for new products.) OR 5. Request voluntary cancellation of the registration(s) of your products for which the data are needed. (This option is not available to applicants for new products.) D« Procedures for Requesting Changes in Testing Methodology and Extensions of Time— ajL EPA recognizes that you may disagree with our conclusions regarding the appropriate ways to develop the required data or how quickly the data must be submitted. If the test procedures you plan to use deviate from (or are not specified in) the registration guidelines or protocols contained in the reports of the Expert Groups to the Chemical Groups, Organization for Economic Cooperation and Development (OECD) Chemicals Testing Programme, you must submit the protocol for Agency review prior to the Initiation of the test. If you think that you will need more time to generate the required data than Is allowed by EPA's schedule, you may submit a request for an extension of time. The extension request must be submitted in writing to the Product Manager. (Footnote continued from previous page) In EPA's opinion, Joint data development by all regis- trants subject to a data requirement or a cost-sharing agreement among all such registrants is clearly in the public interest. Duplication of testing could increase costs, tie up testing facilities, and subject an unnecessarily large number of animals to testing. As noted earlier, EPA has discretion to suspend the registration of a product when a registrant falls to submit data required under PIPRA Section 3(c)(2)(B). EPA has concluded that It should encourage Joint testing rather than duplicatlve testing, and that suspension should be withheld in certain cases. to further this goal. Accordingly, If (1) a registrant has informed us of his intent to develop and submit data required by this Notice; and (2) a second registrant informs EPA that it has made a bona fide offer to the first registrant to share in the expenses of the testing [on terms to be agreed upon or determined by arbitration under PIFRA Section 3(c) (2)(B)(ill)]; and (3) the first registrant has declined to agree to enter into a cost-sharing agreement, EPA will not suspend the second firm's registration. 31 ------- The extension request should state the reasons why you believe that an extension Is appropriate. While EPA considers your request, you must strive to meet the deadline for submitting the required data. 32 ------- TABUS A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON Guideline Citation and Test Name of Test Substance §158.120 Product Chemistry Product Identity: 61-2 - Description of Beginning Materials and Manufacturing Process 61-3 - Discussion of Formation of Impurities Analysis and Certification of Product Ingredients 62-1 - Preliminary Analysis Physical and Chemical Characteristics 63-2 - Color 63-3 - Physical State 63-4 - Odor 63-5 - Melting Point 63-6 - Boiling Point TGAI TGAI TGAI TGAI TGAI TGAI TGAI TGAI Guidelines Status R R CR R R R R R Are Data Footnote Required Number Yes No OP m o O O O n n 2 n 2 n 2 on oa oa oa oa Data Must Be Submitted Within Time Frames Listed Below V. 6 months 6 months 12 months 33 ------- TABLE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON Guideline Citation and Name of Test Test Guidelines Substance Status Data must Be Are Data Footnote Submitted Within Required Number Time Frames Listed Yes No Below 1L §158.120 Product Chemistry (Continued) 63-7 63-8 63-9 63-10 63-11 63-12 63-13 Other 64- 1 - Density, Bulk Density, or Specific Gravity - Solubility - Vapor Pressure - Dissociation constant - Octanol/water partition coefficient - pH - Stability Requirements: I/ - Sutmlttal of samples TOAI R TGAI or PAI R PAI R PAI R PA? R TGAI R TGAI R TGAI, PAI CR [X] o n QD n n C ] [3D m n n n cm n 6 months 6 months 6 months 6 months TGAI » Technical Grade of the Active Ingredient; PAI « Pure Active Ingredient; R » Required; CR - Conditionally Required \l Data must be submitted within the indicated time frame, based on the date of the Guidance Document. 0 6 Month Due Date is 07 ^AR IQRp . 2/ Update as per current product chemistry guidelines (Subdivision D). 3/ The Agency will request samples if /when needed. If requested, the time permitted for subnittal will be 6 months. 34 ------- TABLE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON §158.125 Residue Chemistry 171-2 - Chemical Identity TGAI partially 171-3 - Directions for Use — partially 171-4 - Nature of Residue (Metabolism) - Plants PAIRA partially 00010517, 00051652, 00039657, 00051653, 00106221, .00051655, 00106230, 00040516, 00108281, 00039852, 00052052, 00052050, 00039282, 00051656, 00010518, 00039285, 00039284, 00039283, 00039656, 00039668, 00039666, 00039671, 00039661, 00039660, 00039664, 00039670, 00039672, 00039280, 00039669, 00051654, 00039665, 00039281, 00039667, 00040519, 00039659, 00040184, 00039852, 00039278, 00040188, 00084714, 00039279, 00052055, 00084715 3/ yes 6 months I/ - yes 6 months 5A/ yes 18 months - Animals PAIRA and Plant Metabolites 35 7,8/ partially yes 18 months Cows 155039850, 00044781, 00039851, 00040110, 00039848, 00039849, ------- TABLE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON Data Requirements Conpositlon" Does EPA Have Data To Satisfy This I/ Requirement? (Yes, No, or Partially) Bibliographic Citation §158.125 Residue Chemistry - Continued Goats 00039853, 00039854, 00039818, 00040111, Poultry 00039856, 00011782, 00039848, 00039855, 00039857, Swine 00137904 Laboratory Animals Rat 00051652, 00039848, 00039853, 00040111, 00063615 Rabbit 00039861, 00039860 Mice 00039862 Must Additional Data Be Submitted Under PIPRA § 3(c)(2)(B)? Time Frames For Data Submission 2/ 36 ------- TABIE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON Data Requirement Does EPA Have Data To Satisfy This I/ Requirement? (Yes, Composition No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under PIPRA § 3(c)(2)(B)? Time Frames for Data Submission 2/ §158.125 Residue Chemistry - Continued 171-4 - Residue Analytical Method - Plant residues TGAI and Metabolites yes - Animal residues 171-4 - Storage stability TGAI and Metabolites partially yes 171-4 - Magnitude of the Residue- Residue Studies for Each Food Use - - Crop Group #1 - Legune Vegetables (Succulent or Dried) o Soybeans — Crop field trials TEP yes — Processed Pood/Peed EP yes (plant and animal) 00051657, 00106263, 00023509, 00040521, 00039851, 00014782, 00039658, 00040522, 00040185, 00040517, 00040186, 00040187, 00040785 incl. above 00039290, 00040189 00040193 (crop and 00106228, 00040182, 00040181, 00079082, 00040174, 00031796, 00106263, 00023507, 00040173, 00040184 37 processed) 00040172, 00040177, 00040176, 00040180, 00051658, 00040183, 00040178, 00040179, 00040186, 9/ reserved 9,107 yes 15 months 9/ reserved reserved 9/ reserved 9/ ------- TABLE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON Must Additional bata Be Submitted Under PIPRA § 3(c)(2)(B)7 Time Frames for Data Submission £/ Data Requirement Composition" Does EPA Have Data To Satisfy This I/ Requirement? (Yes, No or Partially) Bibliographic Citation §158.125 Residue Chemistry - Continued o Beans, succulent and dried Beans, succulent (except lima beans) — Crop Field Trials TEP Processed Food/Feed EP yes no 00106213, 00106263, 00023507, 00026208, / reserved yes 24 months Beans, dried — Crop Field Trials Beans, lima — Crop Field Trials o Peas, succulent and dried Peas, succulent -- Crop Field Trials Peas, dried — Crop Field Trials TEP TEP TEP TEP yes yes yes partially 00106243, 00106263, 00040520, 00023507, 00106231, 00023507, 00106263, 00051911, 00040520 00106263, 00051912, 00040521, 00023507, 00040520, 00106243 00051912 reserved 9/ reserved 9/ 9/ reserved 9.12/ yes 18 months 38 ------- TABIE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON Data Requirement Does EPA Have Data To Satisfy I/ This Require- Conposltlon ment? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under PIPRA § 3(c)(2)(B)? Time Frame for Submission*?/ §158.125—Residue Chemistry, cont. Crop Group #2—Foliage of Legume Vegetable Group o Soybean forage — Crop Field Trials TEP o Soybean hay — Crop Field Trials o Bean forage and nay — Crop Field Trials o Pea Forage and Vine Hay — Crop Field Trials Crop Group 03—Fruiting Vegetable Group (except cucurbits) o Bohemian chill peppers — Crop Field Trials TEP TEP TEP partially yes yes yes 00010183, 000*10176, 00079082, 00051658, 00106227, 00079082, 00010183, 00031796, 00051658, 00106236, 00106228, 000519H, 00106236, 00106231, 00106213, 00010521, 00051912, TEP yes 00106215 9,13/ yes 18 months reserved 9/ reserved i/ 00106213, 00051912, reserved" 9/ reserved s/ 39 ------- TABLE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON Does EPA Have Data To Satisfy I/ Otils Require- Bibliographic- Data Requirement Composition" merit? (Yes, No Citation or Partially) §158.125 Residue Chemistry - Continued Crop Group M—Cereal Grains Group o Conij grain — Crop Field Trials TEP yes — Processed Food/Feed EP yes o Corn^ fresh (Incl. sweet corn) — Crop Field Trials TEP yes — Processed Food/Feed EP no o Rice, grain ' — Crop Field Trials , TEP yes (crop and processing) 00023507, 00106252 00023508, 00106254 00106263, 00106251 00023511, 00108303 00023511, 00106238 00106253, 00040171 (crop and processing) 00106238, 00010831, 00010829, 00040820, 00040822, 00040819, 00040833, 00052053, 00040824, 00040834, 00040828, 00040823, 00040832, 00040830, 00040825, 00040821, 00084711, 00040824, Must Additional Data Be Submitted Under FIFRA § 3(c)(2)(B)7 Time Fr Submit on 2/ I/ reserved reserved J1 reserved reserved" JJ reserved — Processed Food/Feed o Sorghum, grain — Crop Field Trials — Processed Food/Feed EP TEP EP yes yes no Incl. above 00126689 9/ reserved i/ reserved i/ reserved ------- TABLE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON Data Requirement Composition" Does EPA Have Data To Satisfy I/ Tills Require- ment? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under PIPRA § 3(c)(2)(b)? Time Frame for Submission?/ §158.125 Residue Chemistry, cont. Crop Group #5—Forage, Fodder, and Straw of Cereal Grains Group o Corn forage and fodder — Crop Field Trials o Rice straw — Crop Field Trials o Sorghum fodder and forage — Crop Field Trials Miscellaneous.Crops Not Included In Any Crop Grouping o Peanuts (kernels) — Crop Field Trials — Processed Food/Feed TEP yes TEP yes TEP yes TEP EP yes yes 00106254, 00106252 00106253, 00106251, 00040171, 00106238, 00108303, 00023511, 00106263 00010833, 00106238, 00010834, 00052053, 00040823, 00040827, 00040829, 00126689 00040825, 00040821, 00040822, 00040820, 00040831, 00040832, 00040829 (crop and processing) 00106263, 00023507, Q0106237, 00023511, Incl. above 9/ reserved reserved 9/ reserved 9/ reserved 9/ reserved' 9/ ------- 10 TABLE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BEMTAZON * Data Requirement §158.125 Residue Chemistry, cont. o Peanut hulls — Crop Field Trials o Peanut forage and hay — Crop Field Trials o Mint — Crop Field Trials — Processed Food/Feed Magnitude of Residue In Meat, Milk Poultry, Eggs Food Handling 171-5 - Reduction of Residue 2p_/ 171-6 - Proposed Tolerance Does EPA Have Must Additional Data Data To Satisfy Be Submitted Under I/ This Require- Bibliographic FIFRA § 3(c)(2)(b)7 Composition"" ment? (Yes, No Citation TJjne Frame for or Partially) Submission2/ TEP yes TEP yes TEI* yes EP yes TGAI or Plant yes Metabolites 18/ EP N/A Residue of Concern Residue of Concern yes 00023511, 00106237 00106237, 00023511 (crop and processing) 00023511, 00106211, 00106263, 00023507 00108303, 00039819, 00039856, 00039855, 00039811, 00137901 see 171-1 I/ reserved I/ reserved i/ reserved reserved" IV reserved no 19/ yes 9 months 21/ reserved 171-7 - Reasonable Grounds In Support of Petition 171-13 - Subnittal of Analytical Reference Standards22 PAIRA 42 ------- 11 TABLE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON Data Requirement Composition" Does EPA Have Data To Satisfy I/ This Require- ment? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under PIPRA § 3(c)(2)(b)? Time Frame for Submission^/ §158.125 Residue Chemistry, cont. I/ Composition: TOAI - Technical grade of the active Ingredient; PAIRA Typical end-use product; EP « End-use product. Pure active Ingredient, radlolabelled; TEP = thin Ah^r^fUsAted 21 Data must be submitted within i^olnd^Sftted time frame, based on the date of the Guidance Document. 0 6 Month Due Date is 2 < 0 15 Month Due Date Is 0 18 Month Due Date is 0 21 Month Due Date is 3/ See Product Chemistry Table (61-2 and 62-3). V A restriction against grazing Is required for at least 12 days after the last treatment of corn f orage/f odder. A 50-day grazing restriction Is required for peanut forage and hay. J5/ The residues in plants, not extractable with MeCH and composing 50-67/t of total, should be better characterized. . 6/ The 6-hydroxy and the 8-hydroxy metabolites are residues of toxicologlcal concern and are to be Included with bentazon In the tolerances on crops. 7/ The metabolism in animals is not understood as the acid hydrolysis procedure was not run on any of the methanol extracts of eggs and poultry tissues. This is a data gap and must be corrected. 8/ Tolerance for residues In animal products must be expressed In terms of combined residues of AIBA plus bentazon. There are no residues of the 6- and 8-hydroxy metabolites in animals which would require representation In the tolerances for animal products. 9/ In light of the need for additional metabolism data noted above, it is possible that additional residue studies for new metabolites of concern will be required. If needed, these studies should reflect representative growing regions, the maximum registered use, sample chromatographs, and methodology which determines the terminal residue of concern. If the residue samples are stored for a long period of time, storage stability studies for parent and metabolites of concern will be needed. If detectable residues of bentazon or metabolites of toxicologlcal concern occur in grain, a milling study will be needed to show the distribution of these residues in the milled fractions. These are potential data gaps. 43 ------- TABIE A 12 GENERIC DATA REQUIREMENTS FOR BEMTAZON/SODIUM BENTAZON §158.125 Residue Chemistry, cent. 10/ The recoveries of bentazon from milk at fortifications of 0.05 and 0.1 ppm are not acceptable and must be Improved. ll/ Data on residues In cannery waste are required. 12/ Testing Is required In Idaho and Washington. 137 Testing Is required In Tennessee and Missouri. IV Methods and quantitative analyses will be needed If residues of toxlcologlcal concern are Identified from requested metabolism studies. 18/ Sodium bentazon Is not labeled for use In food/feed handling establishments or other Indoor sites where food/feed could be contaminated. 19/ Reduction of residue data are required whert the assumption of tolerance level residues would result In predicted exposure at an unsafe level. Data on the level of residue In food as consumed will be used to obtain a more precise estimate of potential dietary exposure. The Agency recommends that such data be generated to support all pesticides requiring a tolerance In case new data are revealed which Indicate that the pesticide Is more toxic than Initially determined — 10 CPR §158.125(b)(ll). 20/ Includes filing fee. 21/ Changes may be required, depending on the outcome of requested studies. 22/ The Agency will request analytical reference standards If/when needed. 44 ------- 13 TABLE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON I/ Data Requirement Composition §158.130 Environmental Fate DEGRADATION STUDIES-LAB: 161-1 - Hydrolysis TGAI or PAIRA Photodegradatlon 161-2 - In water TGAI or PAIRA 161-3 - On soil TGAI or PAIRA 161-4 - In Air TGAI or PAIRA METABOLISM STUDIES-LAB: 162-1 - Aerobic Soil TGAI or PAIRA • 162-2 - Anaerobic Soil TGAI or PAIRA 162-3 - Anaerobic Aquatic TGAI or PAIRA 162-4 - Aerobic Aquatic TGAI or PAIRA MOBILITY STUDIES:. 163-1 - Leaching and TGAI or PAIRA Adsorption/Desorption 163-2 - Volatility (Lab) TEP 163-3 - Volatility (Field) TEP Use 2/ Pattern ABC ABC : A N/A AB A C C ABC N/A N/A Does EPA Have Must Additional Data Data To Satisfy Be Submitted Under This Require- Bibliographic FIFRA § 3(c)(2)(B)? ment? (Yes, No Citation Time Frame for Data or Partially) Submission 3/ no yes no yes no yes noV partial 00040204, 00040208 yes5 00051659 yes 00040204, 00040208 no no yes no yes partial 0004 1081 yes6/ noV noV 9 months 9 months 9 months 27 months 27 months 27 months 12 months 45 ------- 11 TABIE A .GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON Data Requirement §158.130 Envirormental Pate - DISSIPATION STUDIES— FIELD: 161-1 - Soil 161-2 - Aquatic (Sediment) 161-3 - Forestry 161-1 - Combination an! I/ Composition Continued TEP TEP TEP Use 2/ Pattern"" AB C N/A N/A Does EPA Have Data To Satisfy This Require- Bibliographic ment? (Yes, No Citation or Partially) no no Must Additional Data Be Submitted Under FIFRA § 3(c)(2)(B)? Time Frame for Data Submission 3/ yes7V 27 months yes 27 months no8/ Tank Mixes 161-5 - Son, Long-term ACCUMULATION STUDIES; 165-1 - Rotational Crops (Confined) 165-2 - Rotational Crops (Field) TEP PAIRA TEP 165-3 - Irrigated Crops TEP 165-1 - In Fish TGAI or PAIRA 165-5 - In Aquatic Non-Target TEP Organisms A A C ABC N/A no no no partial 00108300" 12/ no9/ yes10/ 30 months yes10/ 39 months yes11/ 30 months yes12/ 12 months V Composition: TGAI * Technical grade of the active Ingredient; PAIRA » Pure active ingredient, radiolabelled; TEP » Typical end-use product. 2/ The use patterns are coded as follows: A«Terrestrlal , Food Crop; B"Terrestrlal , Non-Food; C«Aquatic, Food Crop; D=Aquatlc, Non-Food; E=Greenhouse, Food Crop; F=Qreenhouse, Non-Food; G=Forestry; H=Dcmestic Outdoor; I=Indoor. ------- TABIE A 15 ' GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BEMTAZON §158.130 Envirormental Pate, cont. 3/ Data must be submitted witK^the. iodtoatad time frame, based on the date of the Guidance Document. ~ ° 9 Month Due Date Is 0 12 Month Due Date Is 0 27 Month Due Date Is 0 30 Month Due Date Is 0 39 Month Due Date Is Q'f QFC 19B£ V Data are not required due to the relatively low vapor pressure of bentazon. 5_/ Additional work should be done to chemically Identify, If feasible, other soil metabolites that may have formed. 6/ Data on leaching of unaged bentazon In sandy clay loam and loamy sand soils are acceptable. The following additional data are required: (1) leaching studies on parent conpound and degradation products for two nore soil types; (2) data on the leaching of degradation products for the two soil types already accepted for column leaching; and (3) adsorptlon/desorption studies on sediment. 7/ The following studies would be acceptable If data are submitted to Indicate that the test material used was a typical end-use product: MRID 00108287, 00108288, 00011105, 00011100, 00011390, 00106226, 00011101, 00011101, 00011102, 00108296. 8/ Data requirements for combination products and tank mixes are not addressed In this standard. £/ Data are not required since results of valid aerobic soil metabolism and terrestrial field dissipation studies indicate that 50% of residues dissipate prior to recommended subsequent application. 10/ For crops rotated on treated areas, any one of the following will apply: (a) A tolerance must be obtained for the rotated crop. (b) The product label must Include a restriction against the rotation of crops used for food or feed which are not registered for use with sodium bentazon. (c) Data must be provided to determine time Intervals at which rotated crops planted on treated areas will be free of pesticide residues. 47 ------- TABLE A 16 GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON §158.130 Environmental Rite, cont. ll/ For sodium bentazon use on rice, any one of the following will apply: (a) A tolerance must be obtained for any crop used for food or feed that Is exposed to Irrigation water containing bentazon or sodium bentazon residues. (b) The product label must Include a restriction against the use of Irrigation water containing bentazon or sodium bentazon residues on crops/grown for food or feed. (c) Data must be provided to demonstrate conditions under which rice Irrigation water can be used on other crops without resulting In Illegal plant residues. 12/ Data on residue accumulation In fish are required; a study on catfish Is preferred. The chemical name and structure of the bentazon residue "NISAA" mentioned In the crawfish uptake study (MRID 00108300) Is needed. 48 ------- 17 TABIE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON I/ Data Requiranent Composition §158.135 Toxicology ACUTE TESTING: 81-1 - Acute Oral Toxlcity - Rat 81-2 - Acute Dermal Toxlcity - Rabbit 81-3 - Acute Inhalation Toxlcity - Rat 81-7 - Delayed Neurotoxicity - Hen SUBCHRONIC TESTING: 82-1 - 90-Day Feeding : - Rodent, and - Non-rodent (Dog) 82-2 - 21-Day Dermal - Rabbit 82-3 - 90-Day Dermal - Rabbit 82-1 - 90-Day Inhalation: - Rat 82-5 - 90-Day Neurotoxicity: - Hen -Mammal TGAI TGAI TGAI TGAI TGAI ' TGAI TGAI TGAI TGAI Does EPA Have Data To Satisfy Use 2/ This Require- Bibliographic Pattern ment? (Yes, No Citation or Partially) A,B,C yes 00064314 A,B,C yes 00041088 A,B,C no N/A*1 no A,B,C no A,B,C no A,B,C no N/A5 N/A5 N/A6 N/A6 Must Additional Data Be Submitted Under FIFRA § 3(c)(2)(B)? Time Frame for Data Submission 3/ no no yes no yes yes yes no no no no 9 months 15 months 18 months 12 months ------- 18 TABIE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON Data Requirement Composition §158.1j CHROI 83-1 83-2 83-3 83-1 55 Toxicology - Continued 4IC TESTING: - Chronic Toxicity - TGAI 2 species: - Rodent, and - Non-rodent (Dog) - Oncogenlcity - TGAI 2 species: - Rat (preferred), and - Mouse (preferred) - Teratogenlclty - TGAI 2 species: - Rat - Rabbit - Reproduction - Rat TGAI 2-gfcneratlon Does EPA Have Must Additional Data Data To Satisfy Be Submitted Under I/ Use 2/ This Require- Bibliographic PIPRA § 3(c)(2)(B)7 ~ Pattern"" ment? (Yes, No Citation Time Frame for Data or Partially) Submission 3/_ A,B,C no A,B,C no A{B,C no A,B,C no ' A,B,C no A,B,C no A,B,C no yes 11 yes yes yes yes yes yes 50 months 50 months 50 months 50 months 15 months 15 months 39 months MUTAGENICITY TESTING 81-2 81-2 81-2 - Gene Mutation (Ames Test) TGAI - Structural Chromosomal TGAI Aberration - Other Genotoxlc Effects TGAI A,B,C no A,B,C no A,B,C no yes yes yes 9 months 12 months 12 months SPECIAL TESTING 85-1 - General Metabolism PAI or PAIRA A,B,C no yes i/ 9/ 21 months ------- 19 TABLE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON Data Requirement I/ Composition Use 2/ Pattern Does EPA Have Data To Satisfy This Require- ment? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under PIPRA § 3(c)(2)(B)? Time Frame for Data Submission 3/ §158.135 Toxicology - Continued 86-1 - Domestic Animal Safety Choice N/A" 10/ no V Composition: TOAI « Technical grade of the active Ingredient; PAI « Pure active Ingredient; PAIRA • Pure active Ingredient, radlolabelled; Choice » Choice of several test substances determined on a case-by-case basis. 2/ The use patterns are coded as follows: A«Terrestrlal, Food Crop; B=Terrestrlal, Non-Food; C«Aqautic, Food Crop; D=Aquatlc, Non-Food; EKJreenhouse, Food Crop; F=Greenhouse, Non-Food; G«Forestry; H=Donestic Outdoor; I=Indoor. 3/ Data must be submitted within ^he, ^^flffld time frame, based on the date of the Guidance Document. 0 9 Month Due Date is 0 12 Month Due Date is 0 15 Month Due Date is 0 18 Month Due Date is 0 21 Month Due Date is 0 39 Month Due Date is 0 50 Month Due Date is V Bentazon is neither an organophosphate, nor an analog of a neurotoxic compound, hence no delayed neurotoxicity study Is required. 5_/ This study is not applicable to exposure conditions. 6/ This study is not applicable to exposure conditions. See footnote #1 above. 77 A one-year dog study is required. 8/ Metabolism testing using sodium bentazon Is also required to determine whether there is any difference from bentazon. £/ Although the Agency does not have a chronic data base, there is indication of possible teratogenicity, for example. It Is Important to examine dermal absorption at this time to better understand potential exposure. This will enable the Agency to determine whether adequate margins of safety exist, should'adverse effects be seen In required studies. 10/ There Is no evidence of high acute or subacute toxlcity. 51 ------- 20 TABLE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON Must Additional Data Be Submitted Under PIPRA § 3(c)(2)(B)7 Time Frame for Data Submission 3/ Data Requirement V Use 2/ Composition" Pattern Does EPA Have Data Tfo Satisfy Dils Require- ment? (Yes, No or Partially) Bibliographic Citation §158.110 132-1 132-1 133-3 133-1 §158.112 201-1 201-1 Reentry Protection - Foliar Dissipation - Soil Dissipation - Dermal Exposure - Inhalation Exposure Spray Drift - Droplet Size Spectrum - Drift Field Evaluation TEP TEP TEP TEP TEP TEP N/A N/A N/A N/A N/A N/A- no no no no no no \l Composition: TEP - Typical end-use product. 2/ The use patterns are coded as follows: A-Terrestrlal, Food Crop; B-Terrestrial, Non-Food; C«Aquatic, Food Crop; D=Aquatlc, Non-Food; E=Greenhouse, Food Crop; F=Qreenhouse, Non-Food; G=Forestry; H8Dcmestlc Outdoor; I=Indoor. 52 ------- 21 TABLE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON i/ Data Requirement Composition Use 2_/ Pattern Does EPA Have Data To Satisfy This Require- Bibliographic ment? (Yes, No Citation or Partially) Must Additional Data Be Submitted Under FIFRA § 3(c)(2)(B)7 Time Frame for Data Submission 3/ §158.145 Wildlife and Aquatic Organisms AVIAN AND MAMMALIAN TESTING 71-1 71-2 71-3 71-4 71-5 - Acute Avian Oral Toxicity TGAI - Avian Subacute Dietary TGAI Toxicity - Upland Game Bird, and - Waterfowl - Wild Maranal Toxicity TGAI - Avian Reproduction TGAI - Upland Game Bird, and - Waterfowl - Staulated or Actual Field Testing TEP - Mammals, and - Birds A,B,C A,B,C : A,B,C A,B,C A,B,C A,B,C A,B,C partially 00041804, 00041077 partially 00108851 partially 00108850 no partially 00083345 partially 00124702 no no yes 9 months v yes 9 months I/ yes 9 months no 4,6/ yes 9 months 4t6/ yes 9 months no no AQUATIC ORGANISM TESTING 72-1 - Freshwater Fish Toxicity - Coldwater Fish Species TGAI TEP A,B,C C partially 00041075 partially . 00041076 53 I/ yes 9 months I/ yes 9 months ------- 22 TABLE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON I/ Use 2/ Data Requirement Composition"" Pattern"" Does EPA Have Data To Satisfy This Require- Bibliographic merit? (Yes, No Citation or Partially) Must Additional bata Be Submitted Under FIFRA § 3(c)(2)(B)? Time Frame for Data Submission 3/ §158.145 Wildlife and Aquatic Organisms - Continued 72-2 72-3 and - Warmwater Fish Species - Acute Toxlclty to Freshwater Invertebrates - Acute Toxlclty to TOAI TEP TOAI TEP TOAI A,B,C C A,B,C C partially 00041075 partially 00041076 partially 00106240 no I/ yes yes"" v yes yes 9 months 9 months 9 months 9 months Estuarlne and Marine Organisms 72-4 72-5 72-6 - Flah - Mollusk - Shrimp - Flah Early Life Stage, and - Aquatic Invertebrate Life-Cycle - Fish - Life-Cycle - Aquatic Organism TGAI TOAI TOAI TCAI , PAI or A,B,C A,B,C A,B,C A,B,C A,B,C t A,B,C Degradation no no no no no no no I! yes no 12 months 6/ reserved" 6/ reserved" 6/ reserved" Accumulation Product - Crustacean - Fish - Insect Nymph - Mollusk A,B,C A,B,C A.B.C no no no no ^A no y yes no no ------- 23 TABIE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM EENTAZON Data Requirement I/ Use 21 Composition Pattern Does EPA Have Data To Satisfy This Require- ment? (Yes, No or Partially) Bibliographic Citation Mist Additional Data Be Submitted Under FIFRA § 3(c)(2)(B)? Time Frame for Data Submission I/ §158.115 Wildlife and Aquatic Organisms - Continued 72-7 - Simulated Field Testing TEP - Aquatic Organisms A,B,C no - Actual Field Testing TEP -Aquatic Organisms A,B,C no y reserved 6/ reserved _!/ Composition: TQAI » Technical grade of the;active Ingredient; PAI « pure active Ingredient; TEP » Typical end-use product; 2J The use patterns are coded as follows: A=Terrestrial, Food Crop; B^Terrestrlal, Non-Food Crop; C^Aquatlc, Food Crop; D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Donestlc Outdoor; I=Indoor. 3/ Data must be submitted within the indie ~ ° 9 Month Due Date Is 0.7 j''" 0 12 Month Due Date is 97 Q Li time frame, based on the date of the Guidance Document. V The composition of the test material, including percent active ingredient, must be clarified/verified. 5_/ An oyster study is required regarding the rice use (aquatic) and the turf, corn, and soybean uses (since there are greater than 300,000 acres of each of these in coastal counties). This study is also needed to evaluate the potential for hazard to endangered mussel species. Fish and shrimp studies are not required at this time due to the low toxlcity seen In other aquatic studies. 6/ Tnis study is not required for hazard assessment at the present time. Following Agency review of product and environmental chemistry data requested In this Registration Standard, reevaluation of ecological effects data requirements will be made. 77 See requirement in table under §158.130. ------- TABIE A GENERIC DATA REQUIREMENTS FOR BENTAZCN/SODIUM BBNTAZON Must Additional Data Be Submitted Under PIPRA § 3(c)(2)(B)7 Time Frame for Data Submission 3/ Data Requirement I/ Use 2/ Composition Pattern Does EPA Have Data To Satisfy This Require- ment? (Yes, No or Partially) Bibliographic Citation J158.150 Plant Protection 121-1 - TARGET AREA EF PHYTOTQXICITY NONTARGET AREA PHYTOTOXICITY TIER I 122-1 - Seed Germination/ TOAI Seedling Emergence 122-1 - Vegetative Vigor TOAI 122-2 - Aquatic Plant Growth TGAI TIER II 123-1 - Seed Germination/ TOAI Seedling Emergence 123-1 - Vegetative Vigor TCAI 123-2 - Aquatic Plant Growth TGAI TIER III 121-1 - Terrestrial Field TEP 121-2 - Aquatic Field TEP A A I/ I/ I/ I/ I/ I/ I/ Composition: TGAI » Technical grade of the active ingredient; TEP - Typical end-use product. EP » End-use product. 2_/ The use patterns are coded as follows: A*Terrestrial, Food Crop; B=Terrestrlal," Non-Food Crop; C=Aquatlc, Food Crop; D^Aquatlc, Non-Food; EsGreenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Dcmestic Outdoor; I=Indoor. 3/ These data are not required at this time, In accordance with §158.150. ------- 25 TABIE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON Data Requirement I/ Use 21 Composition Pattern Does EPA Have Data To Satisfy This Require- ment? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under PIPRA § 3(c)(2)(B)? Time Frame for Data Submission 3/ §158.155 Nontarget Insect NONTAROET INSECT TESTING - POLLINATORS; 141-1 - Honey bee acute contact toxlclty TGAI 141-2 - Honey bee - toxlclty TEP of residues on foliage - Honey bee subacute (Reserved) feeding study 111-5 - Field testing for TEP pollinators NONTAROET INSECT TESTING - AQUATIC INSECTS; 142-1 - Acute toxlclty to (Reserved) aquatic Insects 142-1 - Aquatic Insect (Reserved) liio-cycle study 142-3 - Simulated or actual (Reserved) field testing for aquatic Insects 143-1 - NONTARGET INSECT (Reserved) TESTING - PREDATORS thru AND PARASITES 143-3 A,B,C .A,B,C no no yes no 9 months 57 ------- 26 TABLE A GENERIC DATA REQUIREMENTS FOR BENTAZON/SODIUM BENTAZON §158.155 Nontarget Insect - Continued I/ Composition: TGAI » Technical grade of the active ingredient; TEP » Typical end-use product. 2/ The use patterns are coded as follows: A-Terrestrlal, Pood Crop; B-Terrestrlal, Non-Pood; C«Aquatic, Pood Crop: D-Aqautlc, Non-Pood; E'Greenhouse, Pood Crop; F«Greenhouse, Non-Pood; G»Porestry; H=Dcmestlc Outdoor; I«Indoor. 3/ Data must be submitted within the indicated, time frame, based on the date of the Guidance Document. 0 9 Month Due Date is 97 .1UN \\ 58 ------- III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA Note: Unless stated otherwise in Section I, Regulatory Position and Rationale, this Section applies only to manufac- turing use products, not to end use products. A necessary first step in determining which statements must appear on your product's label is the completion and submission to EPA of product-specific data* listed on the form entitled "Product Specific Data Report" (EPA Form 8580-4, Appendix III-l) to fill gaps identified by EPA concerning your product. Under the authority of PIPRA sec. 3(c)(2)(B), EPA has determined that you must submit these data to EPA in order to reregister your product(s). All of these data must be submitted not later than six months after you receive this guidance document. Table B—Product-Specific Data Requirements for Manufacturing Use Products—lists the product specific data you must submit. Data that are required to be submitted are identified in the column of those tables entitled "Must Data By Submitted Under §3(c)(2)(B)." J|/ Product specific data pertain to data that support the formulation which is marketed; it usually includes product chemistry data and acute toxlcity data. 59 ------- 27 TABLE B PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURIN3-USE PRODUCTS CONTAINING SODIUM BENTAZON Guideline Citation and Test Name of Test Substance §158.120 Product Chemistry Product Identity: 61-1 - Product Identity and Disclosure of Ingredients 61-2 - Description of Beginning Materials and Manufacturing Process 61-3 - Discussion of Formation of Impurities Analysis and Certification of Product Ingredients 62-1 - Preliminary Analysis 62-2 - Certification of Limits 62-3 - Analytical Methods to Verify Certified Limit Physical and Chemical Characteristics 63-2 - Color 63-3 - Physical 'State 63-4 - Odor MP MP MP : MP MP MP MP MP MP Guidelines Status R R R CR R R R R R Are Data Required Yes No on n [ft n [ft n [ft n [ft n ra O n m n on n ra Data Must Be Footnote Submitted Within Number Time Frames Listed Below IL 2 6 months 3 6 months 3 6 months 3 . 12 months 3 12 months 3 12 Months 60 ------- 28 TABIE B PRODUCT SPECIFIC DATA. REQUIREMENTS FOR MANUFACTURIM3-USE PRODUCTS CONTAINING SODIUM BENTAZON Guideline Citation and Test Guidelines Name of Test Substance Status t §158.120 Product Chemistry (Continued) Physical and Chemical Characteristics (Cont, 63-7 - Density, Bulk Density, or Specific Gravity 63-12 - pH 63-11 - Oxidizing or Reducing Action 63-15 - Flanmablllty 63-16 - Explodabillty 63-17 - Storage Stability 63-18 - Viscosity 63-19 - Mlscibility 63-20 - Corrosion Characteristics Other Requirements: I/ 61- 1 - Submit tal of samples MP » Manufacturing-use Product; R « Reqult I/ Data must be submitted withinrithei JUKI if 0 6 Month Due Date is * ' MAK 1 0 12 Month Due Date is 0 +> ^ £ -» 1C 0 15 Month Due Date is O 7 Hf1 M( / MP R MP CR MP CR MP CR MP R MP R MP CR MP CR MP R MP CR •ed; CR » Conditionally «fced time frame, based J-K UR Data Must Be Are Data Footnote Submitted Within Required Number Time Frames Listed Yes No Below If [X] [ ] 3 6 months [!Q Hi 3 6 months [ITl [~) 3 6 months n m [7] ["] 3 6 months n m n m n m [IT] [~] 3 15 months n n Required on the date of the Guidance Document. 2_/ An updated statement of composition is needed from BASF Wyandotte Corporation. 3_/ Update as per current Product Chemistry guidelines (Subdivision D). I/ The Agency will request samples if/when needed. If requested/ the time permitted for submittal will be 6 months. ~ O I ------- 29 TABIE B PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURINQ-USE PRODUCTS CONTAINING SODIUM BENTAZON Must Additional Uata Be Submitted Under PIFRA § 3(c)(2)(B)? Time Frame for Data Submission?/ Data Requirement Composition" I/ Does EPA Have Data To Satisfy This Require- ment? (Yes, No or Partially) Bibliographic Citation §158.135 Toxicology ACUTE TESTING 81-1 - Acute Oral Toxlclty - Rat MP 81-2 - Acute Dermal Toxlclty MP - Rabbit 81-3 - Acute Inhalation Toxlclty MP - Rat 81-4 - Primary Eye MP Irritation - Rabbit 81-5 - Primary Dermal MP Irritation - Rabbit 81-6 - Dermal Sensltizatlon - MP Guinea Pig yes yes no I/ I/ no 00064314 00041088 • ••••••••••••••••••••••••••••••••••••••••• ••••••••I no no yes I/ I/ yes I/ Composition: MP » Manufacturing-use product. 2/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document, 0 9 Month Due Date Is * * l/l f*r .U IflUk A\* U l/\*Vt t, 27 JUN1986 3/ No additional data is required at this time using MP. Available studies in these categories have not been re-reviewed for this Registration Standard. 9 months 9 months 62 ------- IV. SUBMISSION OF REVISED LABELING Note; This section applies to all products. PIPRA requires each product to be labeled with accurate, complete and sufficient instructions and precautions, reflecting the results of data concerning the product and its ingredients. Labeling requirements are set out in 40 CPR 162.10 (see Appendix IV-1) and are summarized for products containing this active ingredient as part of this Guidance Document (See Appendix IV-2). Applications submitted in response to this notice must Include draft labeling for Agency review. If you fall to submit revised labeling information complying with this section (supplemented by requirements described in Section I, Regulatory Position and Rationale), EPA may issue a notice of intent to cancel the registration under PIPRA sec. 6(b)(l). A. Label Contents 40 CPR 162.10 requires that certain specific labeling statements appear at certain locations on the label. This is referred to as format labeling. Specific label items listed below are keyed to Appendix IV-2. Item 1. PRODUCT NAME - The name, brand or trademark is required to be located on the front panel, preferably centered In the upper part of the panel. The name of a product will not be accepted if It is false or misleading. Item 2. COMPANY NAME AND ADDRESS - The name and address of the registrant or distributor is required on the label. The name and address should preferably be located at the bottom of the front panel or at the end of the label text. ' ^« Item 3. NET CONTENTS - A net contents statement is required on all labels or on the container of the pesticide. The preferred location is the bottom of the front panel immediately above the company name and address, or at the end of the label text. The net contents must be expressed in the largest suitable unit, e.g., "1 pound 10 ounces" rather than "26 ounces." In addition to English units, net contents may be expressed in metric units. See Appendix IV-1. [40 CFR I62.10(d)] 63 ------- Item 4. EPA REGISTRATION NUMBER - The registration number assigned to the pesticide product must appear on the label, preceded by the phrase "EPA Registration No.," or "EPA Reg. No." The registration number must be set in type of a size and style similar to other print on that part of the label on which it appears and must run parallel to it. The registration number and the required identifying phrase must not appear in such a manner as to suggest or imply recommendation or endorsement of the product by the Agency. See Appendix IV-1. [40 CPR I62.10(e)3 Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment number, preceded by the phrase "EPA Est." is the final estab- lishment at which the product was produced, and may appear In any suitable location on the label or immediate container. It must also appear on the wrapper or outside container of the package if the EPA establishment number on the immediate container cannot be clearly read through such wrapper or container. See Appendix IV-1. [40 CPR I62.10(f)] Item 6A. INGREDIENTS STATEMENT - An ingredients statement is required on the front panel. The ingredients statement must contain the name and percentage by weight of each active ingredient and the total percentage by weight of all inert ingredients. The preferred location is immediately below the product name. The ingredients statement must run parallel with, and be clearly distinguished from, other text on the panel. It must not be placed in the body of other text. See Appendix IV-1. [40 CPR 162.10(g)] Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul- tural formulations, the pounds per gallon of active ingredient must be Indicated on the label. Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel precautionary statements mus't be grouped together, preferably within a block outline. The table below shows the minimum type size requirements for various size labels. Size of Label Signal Word "Keep Out of Reach on Front Panel Minimum Type Size of Children" in Square Inches All Capitals Minimum Type Size 5 and under 6 point 6 point above 5 to 10 10 point 6 point above 10 to 15 12 point 8 point above 15 to 30 14 point 10 point over 30 18 point 12 point Item 7A. CHILD HAZARD WARNING STATEMENT - The statement "Keep Out of Reach of Children" must be located on the front panel above the signal word except where contact with children during distribution or use is unlikely. See Appendix IV-1. [40 CFR I62.10(h)(l)(ii)] 64 ------- Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or CAUTION) is required on the front panel immediately below the child hazard warning statement. See Appendix IV-1 . [40 CPR 162.10 (h)(l)(i)] Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products assigned a toxicity Category I on the basis of oral, dermal, or inhalation toxicity, the -word "Poison" shall appear on the label in red on a background of distinctly contrasting color and the skull and crossbones shall appear in immediate proximity to the word POISON. See Appendix IV-1. [40 CPR 162.10(h) (1) (i)] Item 7D. STATEMENT OP PRACTICAL TREATMENT - A statement of practical treatment (first aid or other) shall appear on the label of pesticide products in toxicity Categories I, II, and III. See Appendix IV-1. [40 CPR I62.10(h)(l)(iii)] Item 7E. REFERRAL STATEMENT - The statement "See Side (or Back) Panel for Additional Precautionary Statements" is required on the front panel for all products, unless all required precautionary statements appear on the front panel. See Appendix IV-1. [40 CPR I62.10(h) (1) (ill)] Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The precautionary statements listed below must appear together on the label under the heading "PRECAUTIONARY STATEMENTS." The preferred location is at the top of the side or back panel preceding the directions for use, and it is preferred that these statements be surrounded by a block outline. Each of the three hazard warning statements must be headed by the appropriate hazard title. See Appendix IV-1. [40 CPR 162.10 Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a hazard exists to humans or domestic animals, precautionary statements are required indicating the particular hazard, the route(s) of exposure and the precautions to be taken to avoid accident, injury or damage. See Appendix IV-1. [40 CPR 162.10 Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to non- target organisms excluding humans and domestic animals, precautionary statements are required stating the nature of the hazard and the appropriate precautions to avoid potential accident, injury, or damage. See Appendix IV-1. [40 CFR 65 ------- Item 8C. PHYSICAL OR CHEMICAL HAZARD 1. Flammability statement. Precautionary statements relating to flammability of a product are required to appear on the label if it meets the criteria in Appendix IV-3. The require- ment is based on the results of the flashpoint determinations and flame extension tests required to be submitted for all products. These statements are to be located in the side/back panel precautionary statements section, preceded by the heading "Physical/Chemical Hazards." Note that no signal word is used in conjunction with the flammability statements. 2. Criteria for declaration of non-flammability.' The following criteria will be used to determine if a product is non-flammable: a. A "non-flammable gas" is a gas (or mixture of gases) that will not ignite when a lighted match is placed against the open cylinder valve. b. A "non-flammable liquid" is one having a flashpoint greater than 350°P (177°C). c. A "non-flammable aerosol" is one which meets the following criteria: 1. The flame extension is zero inches; 11. There is no flashback; and ill. The flashpoint of the non-volatile liquid component is greater than 350°F (177°C). 3. Declaration of non-flammability. Products which meet the criteria for non-flammability specified above may bear the notation ,"n.on-flammable" or "non-flammable (gas, liquid, etc.)" on the label. It may appear as a substatement to the Ingredients statement, or on a back or side panel, but shall not be highlighted or emphasized (as with an inordinately large type size) In any way that may detract from precaution. 1. Other physical/chemical hazard statements. When chemistry data demonstrate hazards of a physical or chemical nature other than flammability, appropriate statements of hazard will be prescribed. Such statements may address hazards of exploslvity, oxidizing or reducing capability, or mixing with other substances to produce toxic fumes. 66 ------- Item 9A. RESTRICTED USE CLASSIFICATION - PIPRA sec. 3(d) requires that all pesticide formulations/uses be classified for either general or restricted use. Products classified for restricted use may be limited to use by certified applicators or persons under their direct supervision (or may be subject to other restrictions that may be Imposed by regulation). In the Registration Standard, the Agency has (1) indicated certain formulations/uses are to be restricted (Section I Indicates why the product has been classified for restricted use); or (2) reserved any classification decision until appropriate data are submitted. The Regulatory Position and Rationale states whether products containing this active ingredient are classified for restricted use. If they are restricted the draft label(s) submitted to the Agency as part of your application must reflect this determination (see below). If you do not believe that your product should be classified for restricted use, you must submit any Information and rationale with your application for reregistration. During the Agency's review of your application, your proposed classi- fication determination will be evaluated in accordance with the provisions of 1»0 CPR I62.11(c). You will be notified of the Agency's classification decision. Classification Labeling Requirements If your product has been classified for restricted use, the following label requirements apply: 1. Front panel statement of restricted use classification. a. The statement "Restricted Use Pesticide" must appear at the top ,of the front panel of the label. The statement must be set In type of the same minimum size as required for human hazard signal word (see table in HO CFR l62.10(h)(l)(iv) b. Directly below this statement on the front panel, a summary statement of the terms of restriction must appear (including the reasons for restriction If specified in Section I). If use is restricted to certified applicators, the following statement is required: "For retail sale to and use only by Certified Applicators or persons under their direct supervision and only for those uses covered by the Certified Applicator's Certification.1' 2. Some but not all uses restricted. If the Regulatory Position and Rationale states that some uses are classified for restricted use, and some are unclassified, several courses of action are available: 67 ------- a. You may label the product for Restricted use. If you do so, you may Include on the label uses that are unrestricted, but you may not distinguish them on the label as being unrestricted. b. You may delete all restricted uses from your label and submit draft labeling bearing only unrestricted uses. c. You may "split" your registration, i.e., register two separate products with Identical formulations, one bearing only unrestricted uses, and the other bearing restricted uses. To do so, submit 'two applications for reregistration, each containing all forms and necessary labels. Both applications should be submitted simul- taneously. Note that the products will be assigned separate registration numbers. Item 9B [There is no Item 9B]. Item 9C. MISUSE STATEMENT - All products must bear the misuse statement, "It Is a violation of Federal law to use this product in a manner Inconsistent with its labeling." This statement appears at the beginning of the directions for use, directly beneath the heading of that section. Item 10A. REENTRY STATEMENT - If a reentry Interval has been established by the Agency, it must be included on the label. Additional worker protection statements may be required in accordance with PR Notice 83-2, March 29, 1983. Item 10B [There is no Item 10B]. Item IOC. STORAGE AND DISPOSAL BLOCK - All labels are required to bear storage ahcT disposal statements. These statements are developed for specific containers, sizes, and chemical content. These instructions must be grouped and appear under the heading "Storage and Disposal" in the directions for use. This heading must be set in the same type sizes as required for the child hazard warning. Refer to Appendix IV-JJ, IV-5, and IV-6 to determine the storage and disposal Instructions appropriate for your products. Item 10D. DIRECTIONS FOR USE - Directions for use must be stated in terms which can be easily read and understood by the average person likely to use or to supervise the use of the pesticide. When followed, directions must be adequate to protect the public from fraud and from personal injury and to prevent unreasonable adverse effects on the environment. See Appendix IV-1. [40 CFR 162.10] 68 ------- B. Collateral Labeling bulletins, leaflets, circulars, brochures, data sheets, flyers, or other written or graphic printed matter which is referred to on the label or which is to accompany the product are termed collateral labeling. Such labeling may not bear claims or representations that differ in substance from those accepted in connection with registration of the product. It should be made part of the response to this notice and submitted for review. V. INSTRUCTIONS FOR SUBMISSION A. For Manufacturing Products (MP) containing (name of pesticide) as sole active ingredient. 1. Within 90 days from receipt of this document, you must submit to the Product Manager in the Registration Division at the address given at the end of this section the "FIFRA Section 3(c)(2)(B) Summary Sheet" EPA Form 8580-1. Refer to Appendix II-3 with appropriate attachments. If on the Summary Sheet, you commit to develop the data, request a minor chemical exemption, present arguments that a data requirement is not applicable, or submit protocols or modified protocols for Agency review, you must also submit a copy of the Summary Sheet (and any supporting information) to the Office of Compliance Monitoring, which will be monitoring the data generated in response to this notice. This information should be submitted to the Office of Compliance Monitoring at the address given at the end of this section. (Actual studies are not to be submitted.) 2. Within 6 months from receipt of this document you must submit to the Product Manager on the Registration Division: a. Confidential .Statement of Formula, EPA Form 8570-4. b. Product Specific Data Report, EPA Form 8580-4 (Appendix III-l). c. Two copies of any required product-specific data (See Tables B). d. Two copies of draft labeling, including the label and associated brochures. If current labeling conforms to the requirements of this guidance document and the results of the short-term data, you may submit such labeling. End use product labeling must comply specifically with the Instructions in Section I (Regulatory Position and Rationale) of this guidance document. The labeling should be either typewritten 69 ------- text on 8-1/2 x 11 Inch paper or a raockup of the labeling suitable for storage in 8-1/2 x 11 inch files. The draft label must indicate the intended colors of the final label, clear indication of the front panel label, and the intended type sizes of the text. e. Evidence of compliance with data support requirements of PIPRA sec. 3(c)(l)(D). Refer to 40 CPR 152.80-152.99 for latest requirements. 3. Within the times set forth in Table A, you must submit to the Registration Division all generic data, unless you are eligible for the formulator's exemption. If for any reason any test is delayed or aborted so that the agreed schedule cannot be met, notify the Product Manager and the Office of Compliance Monitoring. B. For Manufacturing Use Products containing (name of pesticide) in combination with other active ingredients 1. Within 90 days from receipt of this document, you must submit the "PIPRA Section 3(c)(2)(B) Summary Sheet," EPA Form 8580-1. Refer to Appendix II-3 with appropriate attachments. If on the Summary Sheet, you commit to develop the data, request a minor chemical exemption, present arguments that a data requirement is not applicable, or submit protocols or modified protocols for Agency review, you must also submit a copy of the Summary Sheet (and any supporting information) to the Office of Compliance Monitoring, which will be monitoring the data generated in response to this notice. This information should be submitted to the Office of Compliance Monitoring at the address given at the end of this section. (Actual studies are not to be submitted.) 2. Within the times set forth in Table A, you must submit to the Registration Division all generic data, unless you are eligible for the formulator's exemption. If for any reason any test is delayed or aborted so that the agreed schedule cannot be met, notify the Product Manager and the Office of Compliance Monitoring. 70 ------- C. For End Use Products containing (name of pesticide) alone or in combination with other active ingredients; 1. Within 90 days from receipt of this document, you must submit the "PIERA Section 3(c)(2)(B) Summary Sheet," EPA Form 8580-1. Refer to Appendix II-3 with appropriate attachments. If on the Summary Sheet, you commit to develop the data, request a minor chemical exemption, present arguments that a data requirement is not applicable, or submit protocols or modified protocols for Agency review, you must also submit a copy of the Summary Sheet (and any supporting information) to the Office of Compliance Monitoring, which will be monitoring the data generated in response to this notice. This information should be submitted to the Office of Compliance Monitoring at the address given at the end of this section. (Actual studies are not to be submitted.) 2. Within 6 months from receipt of this document you must submit: a. Confidential Statement of Formula, EPA Form 8570-4. b. Product-Specific Data Report, EPA Form 8580-4 (Appendix III-l), if applicable (if Table C lists required product-specific data). c. Two copies of any required product-specific data, if applicable (if Table C lists required product-specific data). d. Two copies of draft labeling, including the label and associated brochures. If current labeling conforms to the requirements of this guidance document and the results of the short-term data, you may submit such labeling. End use product labeling must comply specifically with the instructions in Section I (Regulatory Position and Rationale) of this guidance document. Labeling should be either typewritten text on 8 1/2 x 11 inch paper or a mockup of the labeling suitable for storage In 8 1/2 inch files. The draft label must Indicate the intended colors of the final label, clear indication of the front panel label, and the Intended type sizes of the text. 3. Within the time frames set forth in Table A, submit all generic data, unless you are eligible for the formulator's exemption. 71 ------- D. For intrastate products containing (name of pesticide) either as the sole active Ingredient or In combination with other active Ingredients These products are being called In for full Federal registration. Producers of these products are being sent a letter instructing them how to submit an application for registration. E. Addresses Applications and other required information should be submitted to the following address: Robert Taylor, Product Manager (25) Registration Division (TS-767C) Office of Pesticide Programs Environmental Protection Agency 401 M St., SW. Washington, D.C. 20460 Phone No. (703) 557-1800 The address for submission to the Office of Compliance Monitoring is: Laboratory Data Integrity Program Office of Compliance Monitoring (EN-342) Environmental Protection Agency 401 M St., SW. Washington, D.C. 20460 72 ------- Appendix II-l Guide to Use of This Bibliography 1. CONTENT OP BIBLIOGRAPHY. This bibliography contains citations of all studies considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the Standard. Primary sources for studies In this bibliography have been the body of data submitted to EPA and Its predecessor agencies In support of past regulatory decisions. Selections from other sources Including the published literature, in those Instances where they have been considered, will be Included. 2. UNITS OP ENTRY. The unit of entry In this bibliography Is called a "study." In the case of published materials, this corresponds closely to an article. In the case of unpublished materials submitted to the Agency, the Agency has sought to Identify documents at a level parallel to the published article from within the typically larger volumes in which they were submitted. The resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for purposes of review, and can be described with a conventional bibliographic citation. The Agency has attempted also to unite basic documents and commentaries upon them, treating them as a single study. 3. IDENTIFICATION OP ENTRIES. The entries in this bibliography are sorted numerically by "Master Record Identifier," or MRID, number. This number is unique to the citation, and should be used at any time specific reference is required. It Is not related to the six-digit "Accession Number" which has been used to Identify volumes of submitted studies; see paragraph 2f(d)(4) below for a further explana- tion. In a few cases, entries added to the bibliography late In the review may be preceded by & nine-character temporary identifier. These entries are listed after all MRID entries. This temporary identifier number Is also to be used whenever specific reference is needed. 4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of a citation containing standard elements followed, in the case of material submitted to EPA, by a description of the earliest known submission. Bibliographic conventions used reflect the standards of the American National Standards Institute (ANSI), expanded to provide for certain special needs. 73 ------- Appendix II-l (continued) a. Author. Whenever the Agency could confidently identify one, the Agency has chosen to show a personal author. When no individual was identified, the Agency has shown an identifiable laboratory or testing facility as author. As a last resort, the Agency has shown the first submitter as author. b. Document Date. When the date appears as four digits with no question marks, the Agency took it directly from the document. When a four-digit date is followed by a question mark, the bibliographer deduced the date from evidence in the document. When the date appears as (19??)* the Agency was unable to determine or estimate the date of the document. c. Title. In some cases, it has been necessary for Agency bibliographers to create or enhance a document title. Any such editorial insertions are contained between square brackets. d. Trailing Parentheses. For studies submitted to the Agency in the past, the trailing parentheses include (In addition to any self-explanatory text) the fol- lowing elements describing the earliest known submission: (1) Submission Date. The date of the earliest known submission appears immediately following the word "received." (2) Administrative Number. The next element, Immediately following the word "under," is the registration number, experimental use permit number, petition number, or other administrative number associated with the earliest known submission * * * (3) Submitter. The third element is the submitter, following the phrase "submitted by." When authorship is defaulted to the, submitter, this element Is omitted. (M) Volume Identification (Accession Numbers). The final element in the trailing parentheses identifies the EPA accession number of the volume in which the original submission of the study appears. The six-digit accession number follows the symbol "CDL," standing for "Company Data Library." This accession number is in turn followed by an alphabetic suffix which shows the relative position of the study within the volume. For example, within accession number 123^56,-the first study would be 123^56-Aj the second, 123^56- B; the 26th, 123^56-Z; and the 27th, 123^56-AA. 74 ------- OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Citations Considered to be Part of the Data Base Supporting Registrations Under the Bentazon/Sodiurn Bentazon Standard MR ID CITATION 00023507 BASF Wyandotte Corporation (19??) Residues of Bentazon, 6- and 8- Hydroxy Bentazon in Corn, Soybeans, Peanuts, Dry Beans, Mint, and Succulent Beans and Peas. (Unpublished study received Jun 5, 1979 under 7969-45; CDL:238951-C) 00023508 BASF Wyandotte Corporation (1978) Residues of Bentazon, 6- and 8- Hydroxy Bentazon, and Atrazine in Corn Grain. (Unpublished study received Jun 5, 1979 under 7969-45; CDL:238951-E) 00023509 BASF Wyandotte Corporation (19.74) Determination of Bentazon...8- Hydroxy-Bentazon...and 6-Hydroxy Bentazon...Residues in Whole Soybean Plants of Foliage and Soybean Grain. Method no. 11A dated Jun 25, 1974. (Unpublished study received Jun 5, 1979 under 7969-45; CDL:238951-F) 00023511 BASF Wyandotte Corporation (1977) Determination of Bentazon, 8- Hydroxy Bentazon, and 6-Hydroxy Bentazon in Corn...Peanuts...and Mint (Fresh Hay, Spent Hay and Oil). Method no. 21A dated Jan 25, 1977. (Unpublished study received Jun 5, 1979 under 7969- 45; CDL.-238951-H) 00026208 BASF Wyandotte Corporation (1978) Residues of Bentazon, 6- and 8- Hydroxy Bentazon in Succulent Beans and Peas. (Unpublished study received Jun 5, 1979 under 7969-45; CDL:238951-D) 00031796 Lorberg, J.; Lorberg, J.; Lannon, M.; et al. (1976) Summary of U.S. Crop Residue.Data for Vernam + Basagran on Soybeans. (Un- published study received Aug 11, 1976 under 476-2155; prepared in cooperation with Stewart Brothers and Morse Laboratories, Inc., submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:225431-G) j 00039278 Mahoney, M.D.; Penner, D. (1975) Bentazon transl-ocation and metab- olism in soybean and navy bean. Weed Science^ 23(4) :265-271. (Also in unpublished submission received Oct "30, 1975 under 6G1697; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094826-B) 00039279 Mahoney, M.D.; Penner, D. (1975) The basis for Bentazon selectiv- ity in navy bean, cocklebur, and black nightshade. Weed Science 23(4):272-276. (Also in unpublished submission received Oct 30, 1975 under 6G1697; submitted by BASF Wyandotte Corp., Par- sippany, N.J.; CDL.-094826-C) 75 ------- OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Citations Considered to be Part of the Data Base Supporting Registrations Under the Bentazon/Sodium Bentazon Standard MRID CITATION 00039280 Clark, J.R.; Portnoy, C.E.; Norris, F.A. (1975) 1974 Michigan Field Metabolism Study: Bentazon Soybean Metabolism—Plots 7-11: Part IIA. Total Residue Analysis of Plants: Laboratory Report No. PM- 5. (Unpublished study received Oct 30, 1975 under 6G1697; sub- mitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094S26-D) 00039281 Portnoy, C.E.; DiPrima, S.J.; Clark, J.R. (1975) 1974 Michigan Field Metabolism Study: Bentazon Soybean Metabolism—Plots 7-11: Part IIIB. Characterization of the Extractable Residues from Soybean Tissues: 1. Soybean Grain: Laboratory Report No. PM-5. (Unpublished study received Oct 30, 1975 under 6G1697; submit- ted by BASF Wyandotte Corp., Pasrsippany, N.J.; CDL:094826-E) 00039282 Portnoy, C.E.; Clark, J.R.; Norris, F.A.; et al. (1975) 1974 Mich- igan Field Metabolism Study: Plot 12—Navy Bean Plants: Part IIB. Total Residue Analysis of Plants: Laboratory Report No. PM- 9. (Unpublished study received Oct 30, 1975 under 6G1697; sub- mitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094826-F) 00039283 Portnoy, C.E.; Norton, W.E.; Voulgaris, ?; et al. (1975) 1974 Mich- igan Field Metabolism Study: Plot 12—Navy Bean Plants: Part IIIB. Characterization of the Extractable Residues from Navy Bean Plants: Laboratory Report No. PM-9. (Unpublished study received Oct 30, 1975 under 6G1697; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094826-G) 00039284 Portnoy, C.E.; Clark; J.R.; Norris, F.A.; et al. (1975) 1974 Mis- sissippi Field Metabolism Study: Plot 13— Lima Bean Plants: Part IIB. Total Residue Analysis of Plants: Laboratory Report No. PM-8. (Unpublished study received Oct 30, 1975 under 6G1697; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094826-H) 00039285 Portnoy, C.E.; Horton, W.E.; Voulgaris, ?; et al. (1975) 1974 Mis- sissippi Field Metabolism Study: Plot 13—Lima Bean Plants: Part IIIB. Characterization of the Extractable Residues from Lima Bean Plants: Laboratory Report No. PM-8. (Unpublished study received Oct 30, 1975 under 6G1697; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094826-I) 00039290 Horton, W.E.; Portnoy, C.E.; Otto, S. (1975) Additional Data on the Freezer Storage Stability of Bentazon and Its 6.- and 8-Hy- droxy Conjugates in Soybeans: Report No. SR-26. (Unpublished study received Oct 30, 1975 under 6G1697; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094826-N) 76 ------- OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Citations Considered to be Part of the Data Base Supporting Registrations Under the Bentazon/Sodium Bentazon Standard MRID CITATION 00039656 BASF Wyandotte Corporation (1974) Abstract of the Metabolism of Bentazon in Soybeans. Summary of studies 094134-C through 094134-L and 094134-N through 094134-S. (Unpublished study re- ceived Jul 1, 1974 under 5F1529; CDL:094134-B) 00039657 Analytical Development Corporation (1974) Fate of Bentazon after Application to Soybeans: Project ADC-101. (Unpublished study received Jul 1, 1974 under 5F1529; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094134-C) 00039658 Cannizzaro, R. (1974) Determination of Bentazon..., 8-Hydroxy- bentazon...and 6-Hydroxy-bentazon...Residues in Whole Soybean Plants or Foliage and Soybean Grain. Analytical method no. 11 dated Apr 15, 1974. (Unpublished study received Jul 1, 1974 under 5F1529; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094134-D) 00039659 Penner, D. (1973) Rapid Metabolism of Bentazon in Soybean. (Un- published study received Jul 1, 1974 under 5F1529; prepared by Michigan State Univ., Dept. of Crop and Soil Sciences, submit- ted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094134-E) 00039660 Penner, D. (19??) Selectivity of Bentazon between Soybean and Can- ada Thistle. (Unpublished-study received Jul 1, 1974 under 5F1529; prepared by Michigan State Univ., Dept. of Crop and Soil Sciences, submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094134-F) 00039661 Mahoney, M.D. (1974) Bentazon Selectivity and Metabolism. Mas- ter's thesis, Michigan State Univ.; Dept. of Crop and Soil Sci- ences. (Unpublished study received Jul 1, 1974 under 5F1529; submitted by BASF Wyandotte Corp., N.J.; CDL:094134-G) 00039664 Penner, D. (1973) Report on Bentazon Translocation in Higher Plants. (Unpublished study received Jul 1, 1974 under 5F1529; prepared by Michigan State Univ., Dept. of Crop and Soil Sci- ences, submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094134-J) 00039665 Otto, S.; Drescher, N.; Beutel, P. (1973) Newer Results on the Metabolism of Bentazon in Soybeans (1. Report): Lab. Report No. 1171. (Unpublished study received Jul 1, 1974 under 5F1529; prepared by BASF, AG, submitted by BASF Wyandotte Corp., Par- sippany, N.J.; CDL:094134-K) 77 ------- OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Citations Considered to be Part of the Data Base Supporting Registrations Under the Bentazon/Sodiurn Bentazon Standard MRID CITATION 00039666 Rogers, R.L.; Zaunbrecher, S.J. (1972) Absorption and Transloca- tion of Bentazon in Soybean Plants. (Unpublished study received Jul 1, 1974 under 5F1529; prepared by Louisiana State Univ., Agricultural Experiment Station, submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094134-L) 00039667 Otto, S. (1974) Determination of the Optimum Time of Hydrolysis for the Cleavage of Conjugated Bentazon Metabolites in Soybeans Using ZN Methanolic HC1: Lab. Comm. No. 724. (Unpublished study received Jul 1, 1974 under 5F1529; prepared by BASF, AG, sub- mitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094134-N) 00039668 Roger, J.C. (1974) Report: Determination of Residues in Soybeans . Treated with Radioactive BAS 351-H: Laboratory No. E-7442. (Un- published study received Jul 1, 1974 under 5F1529; prepared by Cannon Laboratories, Inc., submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094134-0) 00039669 Otto, S. (1973) Results from an Experiment Conducted at LSU on the Metabolism of Bentazon in Soybeans: Report No. 1177. (Un- published study received Jul 1, 1974 under 5F1529; prepared in cooperation with BASF, AG and Louisiana State Univ., submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094134-P) 00039670 Otto, S.; Beutel, P. (1974) Further Investigation on the Metab- olism of Bentazon in Soybeans: Lab. Report No. 1211. (Unpub- lished study received Jul 1, 1974 under 5F1529; prepared in cooperation with BASF, AG and Louisiana State Univ., submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094134-Q) 00039671 Penner, D. (1973) Analysis of 14C-Bent'azon Residue from Soybeans Provided by Cannon Laboratories. (Unpublished study received Jul 1, 1974 under 5F1529; prepared by Michigan State Univ., Dept. of Crop and Soil Sciences, submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094134-R) 00039672 Otto, S.; Beutel, P. (1974) Recent Results on the Metabolism of Bentazon in Soybeans (2. Communication): Lab. Report No. 1199. (Unpublished study received Jul 1, 1974 under 5F1529; prepared by BASF, AG, submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094134-S) 00039848 BASF Wyandotte Corporation (1972?) Metabolism of Bentazon in Ani- mals. (Unpublished study received Jul 1, 1974 under 5F1529; CDL.-094133-A) 78 ------- OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Citations Considered to be Part of the Data Base Supporting Registrations Under the Bentazon/Sodium Bentazon Standard MRID CITATION 00039849 Gilman, M,R.; Joseph, T.C. (1973) Report: Determination of Residues in Milk and Tissues of Lactating Cows following the Oral Admin- istration of Radioactive Bas 351-H: Laboratory No. E-6109. (Un- published study received Jul 1, 1974 under 5F1529; prepared.by Cannon Laboratories, Inc., submitted by BASF Uyandotte Corp., Parsippany, N.J.; CDL:094133-B) 00039850 Joseph, T.C. (1974) Report: Determination of Residues in Milk and Tissues of a Lactating Cow following the Oral Administration of Radioactive Bas 351-H: Laboratory No. E-9528. (Unpublished study received Jul 1, 1974 under 5F1529; prepared by Cannon Laboratories, Inc., submitted by BASF Wyandotte Corp., Parsip- pany, N.J.; CDL:094133-C) 00039851 Analytical Development Corporation (1974) Fate of Bentazon after Oral Administration to a Lactating Cow: Project ADC-114-A. Includes analytical method no. 10 dated Jun 10, 1974. (Unpub- lished study received Jul 1, 1974 under 5F1529; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094133-D) 00039852 Otto, S. (1972) Complimentary Investigations on the Metabolism of Bentazon (Bas 351-H) in Soybeans (Experiments Dealing with the Potential Cleavage of Bound Metabolic Complexes by Rumen Fluid): Laboratory Report No. 1103. Translated by H. von Amsberg. (Un- published study received Jul 1, 1974 under 5F1529; prepared by BASF, AG, submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094133-E) • *« 00039853 Joseph, T.C. (1974) Report: Determination of Residues in Tissues, Urine and Feces of a Goat and Rat following the Oral Administra- tion of Methanol Insoluble HC-Residues Present in 14C Bas 351-H Treated Soybeans: Laboratory No. E-7443. (Unpublished study received Jul 1, 1974 under 5F1529; prepared by Cannon Labora- tories, Inc., submitted by BASF Wyandotte Corp., Parisppany, N.J.; CDL:094133-F) 00039854 Clark, J.R.; Wilson, L.A. (1974) Determination of Metabolic Prod- ucts Produced by Nubian Goat after Oral Administration of Methanol-Insoluble HC-Residues Present in Bentazon Treated Soy- beans: Report No. PM-2. (Unpublished study received Jul 1, 1974 under 5F1529; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094133-G) 79 ------- OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Citations Considered to be Part of the Data Base Supporting Registrations Under the Bentazon/Sodium Bentazon Standard MRID CITATION 00039855 Joseph, T.C. (1974) Report: Determination of Residues in Egg and Tissues of Laying Hens following the Oral Administration of Radioactive Bas 351-H: Laboratory No. E-6949. (Unpublished study received Jul 1, 1974 under 5F1529; prepared by Cannon Laboratories, Inc., submitted by BASF Wyandotte Corp., Parsip- pany, N.J.; CDL:094133-H) 00039856 Joseph, T.C. (1974) Report: Determination of Residues in Egg and Tissues of Laying Hens following the Oral Administration of Radioactive Bas 351-H: Laboratory No. E-9551. (Unpublished study received Jul 1, 1974 under 5F1529; prepared by Cannon Laboratories, Inc., submitted by BASF Wyandotte Corp., Parsip- pany, N.J.; CDL:094133-I) 00039857 Analytical Development Corporation (1974) Fate of Bentazon after Oral Administration to Poultry: Project ADC-114-B. Includes analytical method no. 10 dated Jun 10, 1974. (Unpublished study received Jul 1, 1974 under 5F1529; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094133-J) 00039860 Otto, S. (1974) Investigations of Rabbit Urine and Feces after Oral Administration of 14C Bentazon: Laboratory Report No. 1203. (Unpublished study received Jul 1, 1974 under 5F1529; prepared by BASF, AG, submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094133-N) 00039861 Roger, J.C. (1974) Metabolism and Balance Study of 14C-Bas 351-H in a Rabbit: Experiment # 4E-1352-A. (Unpublished study re- ceived Jul 1, 1974 under 5F1529; prepared by Cannon Laborato- ries, Inc., submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094133-0) 00039862 Booth, G.M. (1974) Metabolism of Bentazon in the Mouse (Mus- musculus). (Unpublished study received Jul 1, 1974 under 5F1529; prepared by Brigham Young Univ., Dept. of Zoology, sub- mitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094133-P) 00040110 Cannon Laboratories, Incorporated (1974) Analytical Data and Cal- culations for Results Found in the Text: Report E-9528. (Un- published study received Jul 1, 1974 under 5F1529; CDL:094132-B) 00040111 Cannon Laboratories, Incorporated (1974) Analytical Data and Cal- culations for Results Found in the Text: Report E-7443. (Un- published study received Jul 1, 1974 under 5F1529; CDL:094132-C) 80 ------- OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Citations Considered to be Part of the Data Base Supporting Registrations Under the Bentazon/Sodium Bentazon Standard MRID CITATION 00040171 Eschbach, J.C.; Tietjens, F.; Hanes, R.E.; et al. (1974) Determina- tion of Bentazon and 6+8-Hydroxy Metabolites in Hybrid Sweet Corn from Greenville, Miss.: Field Experiment No. 73-11. (Un- published study received Jul 1, 1974 under 5F1529; prepared in cooperation with United States Testing Co., Inc., submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094i26-A) 00040172 Eschbach, J.C.; Tietjens, F.; Hanes, R.E.; et al. (1974) Determina- tion of Bentazon and 6+8-Hydroxy Metabolites in Soybean Grain from Greenville, Miss.: Field Experiment No. 71-13-1. (Unpub- lished study received Jul 1, 1974 under 5F1529; prepared in co- operation with United States Testing Co., Inc., submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094126-B) 00040173 Eschbach, J.C.; Daniel, J.W. (1974) Determination of Bentazon and 6+8-Hydroxy Metabolites in Soybean Grain from Wilson, Arkansas: Field Experiment No. I-B-3-71. (Unpublished study received Jul 1, 1974 under 5F1529; submitted by BASF Wyandotte Corp., Parsip- pany, N.J.; CDL:094126-C) 00040174 Eschbach, J.C.; Tietjens, F.; Hanes, R.E. (1974) Determination of Bentazon and 6+8-Hydroxy Metabolites in Soybean Grain from Greenville, Miss.: Field Experiment No. 72-99. (Unpublished study received Jul 1, 1974 under 5F1529; prepared in cooperation with United States Testing Co., Inc., submitted by BASF Wyan- dotte Corp., Parsippany, N.J.; CDL:094126-D) 00040176 Eschbach, J.C.; Weishar, A.L.; Wilson, L.; et al. (1974) Determina- tion of Bentazon and 6+8-Hydroxy Metabolites in Soybean Forage and Grain from Waukee, Iowa: Field Experiment No. IV-B-5-72. (Unpublished study received Jul 1, 1974 under 5F1529; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094127-B) 00040177 Eschbach, J.C.; Tietjens, F.; Bonner, W.P.; et al. (1974) Determi- nation of Bentazon and 6+8-Hydroxy Metabolites in Soybean Grain, Meal & Oil from Greenville, Miss.: Field Experiment No. 73-13. (Unpublished study received Jul 1, 1974 under 5F1529; prepared in cooperation with United States Testing Co., Inc. and Texas Engineering Experiment Station, Cottonseed Products Research Laboratory, submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094127-C) 00040178 Eschbach, J.C.; Hendrick, L.W.; Carter, C.; et al. (19.74) Determi- nation of Bentazon and 6+8-Hydroxy Metabolites in Soybean Grain from Bird Island, Minnesota: Field Experiment No. III-B-202-73. (Unpublished study received Jul 1, 1974 under 5F1529; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094128-A) 81 ------- OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Citations Considered to be Part of the Data Base Supporting Registrations Under the Bentazon/Sodium Bentazon Standard MRID CITATION 00040180 Eschbach, J.C.; Ascheman, R.E.; DiPrima, S.; et al. (1974) Determi- nation of Bentazon and 6+8-Hydroxy Metabolites in Soybean Grain from Adel, Iowa: Field Experiment No. IV-B-206-73. (Unpublished study received Jul 1,"1974 under 5F1529; submitted by BASF Wy- andotte Corp., Parsippany, N.J.; CDL:094128-C) 00040181 Eschbach, J.C.; Daniel, J.W.; Wilson, L.; et al. (1974) Determina- tion of Bentazon and 6+8-Hydroxy Metabolites in Soybean Grain from Keiser, Arkansas: Field Experiment No. VIII-B-28-73. (Un- published study received Jul 1, 1974 under 5F1529; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094128-D) 00040182 Eschbach, J.C.; Thompson, J.; Hanes, R.E.; et al. (1974) Determina- tion of Bentazon and 6+8-Hydroxy Metabolites in Soybean Grain from Marion Co., South Carolina: Field Experiment No. VII-A-62- 73. (Unpublished study received Jul 1, 1974 under 5F1529; pre- pared in cooperation with United States Testing Co., Inc., sub- mitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094128-E) 00040183 Eschbach, J.C.; Carter, C.; Hendrick, L.W.; et al. (1974) Determi- nation of Bentazon and 6+8-Hydroxy Metabolites in Soybean For- age, Straw, and Grain from Prior Lake, Minnesota: Field Experi- ment No. III-B-6-72. (Unpublished study including published data, received Jul 1, 1974 under 5F1529; prepared in cooperation with Harris Laboratories, Inc. and Univ. of Minnesota, Agricul- tural Experiment Station, submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094128-F) 00040184 BASF Wyandotte Corporation (1974) Summary of Bentazon, 8-Hydroxy- Bentazon, and 6-Hydroxy-Bentazon Residues in Soybean Foliage, Straw, Grain, Meal, Crude;0il, and Rotational Crops: Methods and Results. (Unpublished study received Jul 1, 1974 under 5F1529; CDL:094129-A) 00040185 Cannizzaro, R.I. (1974) Determination of Bentazon [3-Isopropyl-lH- 2,l,3-benzothiadiazin-4-(3H)-one 2,2-dioxide], 8-Hydroxy-Benta- zon [8-Hydroxy-3-isopropy1-1H-2,l,3-benzothiadiazin-4-(3H)-one 2,2-dioxide], and 6-Hydroxy Bentazon [6-Hydroxy-3-isopropyl-lH- 2,l,3-benzothiadiazin-4-(3H)-one 2,2-dioxide] Residues in Whole Soybean Plants of Foliage and Soybean Grain. Method no. 11A dated Jun 25, 1974. (Unpublished study received Jul 1, 1974 un- der 5F1529; prepared in cooperation with Analytical. Development Corp. and others, submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094129-B) 82 ------- OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Citations Considered to be Part of the Data Base Supporting Registrations Under the Bentazon/Sodium Bentazon Standard MRID CITATION 00040186 Cannizzaro, R.I. (1974) Determination of Bentazon, 8-Hydroxy Benta- zon and 6-Hydroxy Bentazon Residues in Soybean Meal and Soybean Oil. Method no. 12 dated Jun 25, 1974. (Unpublished study re- ceived Jul 1, 1974 under 5F1529; prepared in cooperation with Analytical Development Corp., submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094129-C) 00040187 Cannizzaro, R.I. (1974) Specificity of BWC Agricultural Chemicals Method No. 11 for the Determination of Bentazon, 8-Hydroxy-Bent- azon and 6-Hydroxy-Bentazon Residues in Soybean Foliage, Straw, Grain, and Method No. 12 for Residues in Soybean Meal and Crude Oil by Gas Chromatography: Report No. SR-2. (Unpublished study. received Jul 1, 1974 under 5F1529; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094129-D) 00040188 Otto, S. (1974) Hydrolysis of Conjugated 6- and 8-Hydroxy-Bentazon with 2N HC1 Anhydrous Methanol: Investigation of Optimum Time of Hydrolysis and Hydrolytic Consistency: Report No. SR-3. (Unpub- lished study received Jul 1, 1974 under 5F1529; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094129-E) 00040189 Otto, S. (1974) Freezer Storage Stability of Bentazon and Its 6- and 8-Hydroxy Conjugates in Soybeans: Report No. SR-4. (Trans- lation, unpublished study received Jul 1, 1974 under 5F1529; prepared by Analytical Development Corp., submitted by BASF Wy- andotte Corp., Parsippany, N.J.; CDL:094129-F) t •* « 00040193 Wilson, L.A. (1974) Statistical Evaluation of BWC Ag. Chem. Methods 11A and 12 Based upon Recovery Studies from Soybean Foliage, Grain, Straw, Meal, and Oil: Report No. SR-9. (Unpublished study received on unknown date under 5F1529; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094129-J) 00040204 Drescher, N.; Otto, S. (1973) Degradation of Bentazon (Bas 351-H) in Soil: Report No. 1140. 2nd rept. (Translation; unpublished study received Jul 1, 1974 under 5F1529; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094131-D) 00040208 Drescher, N.; Otto, S. (1973) Degradation of Bentazon (Bas 351-H) in Soil (3rd Report): Report No. 1149. (Trans,!ation; unpub- lished study received Jul 1, 1974 under 5F1529; prepared by BASF, AG, submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094131-H) 83 ------- OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Citations Considered to be Part of the Data Base Supporting Registrations Under the Bentazon/Sodium Bentazon Standard MRID CITATION 00040516 BASF Wyandotte Corporation (1975) Metabolism in Crops: [Bentazon]. Summary of studies 094825-B through 094825-D, 094825-F, 094825- H and 094825-J. (Unpublished study received Oct 30, 1975 under 661697; CDL:094825-A) 00040517 Clark, J.R.; Portnoy, C.E.; Norris, F.A.; et al. (1975) 1974 Michi- gan Field Metabolism Study: Bentazon Soybean Metabolism—Plots 7-11: Laboratory Report No. PM-5. (Unpublished study received Oct 30, 1975 under 6G1697; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094825-D) 00040518 Portnoy, C.E.; Clark, J.R.; Norris, F.A.; et al. (1975) 1974 Michi.- gan Field Metabolism Study: Plot 12—Navy Bean Plants: Laborato- ry Report No. PM-9. (Unpublished study received Oct 30, 1975 under 6G1697; submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094825-F) 00040519 Portnoy, C.E.; Clark, J.R.; Norris, F.A.; et al. (1975) 1974 Mis- sissippi Field Metabolism Study: Plot 13—Lima Bean Plants: Lab- oratory Report No. PM-8. (Unpublished study received Oct 30, 1975 under 6G1697; submitted by BASF Wyandotte Corp., Parsippa- ny, N.J.; CDL:094825-H) 00040520 BASF Wyandotte Corporation (1975) Residue Data & Methodology: [Ben- tazon]. Summary of studies 094825-K through 094825-N. (Unpub- lished study received Oct 30, 1975 under 6G1697; CDL:094825-J) 00040521 BASF Wyandotte Corporation (1975) Determination of Bentazon..., 8- Hydroxy Bentazon..., and 6-Hydroxy Bentazon...Residues in Seed and Pod Vegetable Forage, Hay, Pods, and Seeds. Method no. 19 dated Oct 24, 1975. (Unpublished study received Oct 30, 1975 under 6G1697; prepared in cooperation with Analytical Develop- ment Corp. and BASF, AG; CDL:094825-K) 00040522 Horton, W.E.; Portnoy, C.E. (1975) Specificity of BWC Agricultural Chemicals Method No. 19 for the Determination of Bentazon, 8-Hy- droxy Bentazon and 6-Hydroxy Bentazon Residues in Seed and Pod Vegetable Forage, Hay, Pods and Seeds: Report No. SR-24. (Un- published study received Oct 30, 1975 under 6G1697; submitted by BASF Wyandotte Corp., Parsippany, N.O.; CDL:094825-L) 00040785 Nilles, G.P.; Zabik, M.J. (1974) Photochemistry of Bioactive Com- pounds: Multiphase Photodegredation and Mass Spectral Analysis of Basagran. (Unpublished study received Jul 1, 1974 under 5F1529; prepared by Michigan State Univ., Pesticide Research Center and Depts. of Entomology and Chemistry, submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:094138-C) 84 ------- |